FDA-cleared beauty device database

65 at-home LED, IPL, laser, microcurrent, RF and acne light devices, each with its FDA 510(k) number, cleared use, wavelength or energy, and US list price.

Source: FDA 510(k) database, checked Oct 23, 2026. Download the CSV (65 rows).

The numbers

52 of 65 carry an FDA number: 45 different 510(k)s and 1 De Novo.
13 have no 510(k) on file under the name they’re sold as. 9 of those are called FDA-cleared on a US sales page.
630 nm is the most common LED wavelength (15 devices), then 830 nm (12) and 415 nm (10).
$395 is the median US list price of an LED device here. IPL and laser hair removal: $389.48. Microcurrent: $329. Acne light: $169.

65 devices

We earn a commission if you buy through these links.

FDA records, cleared uses and list prices for 65 at-home beauty devices
					Cleared use			Shop	Notes
BON CHARGE Red Light Face Mask	BON CHARGE	LED light therapy	FDA cleared under another name K253086 FDA record name: LED Light Therapy Device (Models: SG-FM, SG-FE)	Dec 19, 2025	Treatment of wrinkles (model SG-FE).	630 nm, 850 nm 510(k) summary K253086	$349 at boncharge.com · Source · Oct 23		Cleared as LED Light Therapy Device, model SG-FE (Sunglor Technology). FDA’s device listing puts the BON CHARGE mask, model SG-FE, under K253086.
Braun Silk-expert Pro 3	Braun	IPL / laser hair removal	FDA cleared K190366 FDA record name: BRAUN Silk Expert Pro 3	Mar 18, 2019	Removal of unwanted hair; permanent reduction in hair regrowth.		$249.99 at us.braun.com · Source · Oct 23	Shop at Amazon	On sale for $199.99 on Oct 23, 2026, and out of stock at Braun.
Braun Silk-expert Pro 5	Braun	IPL / laser hair removal	FDA cleared K190354 FDA record name: BRAUN Silk.expert Pro 5	Mar 18, 2019	Removal of unwanted hair; permanent reduction in hair regrowth.		$469.99 at us.braun.com · Source · Oct 23	Shop at Amazon
Braun Skin i.expert	Braun	IPL / laser hair removal	FDA cleared K230911	Apr 27, 2023	Removal of unwanted hair; permanent reduction in hair regrowth.		$599.99 at us.braun.com · Source · Oct 23	Shop at Amazon
CurrentBody Skin LED Light Therapy Mask Series 2	CurrentBody	LED light therapy	FDA cleared K250966 FDA record name: CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)	Jun 25, 2025	Treatment of full-face wrinkles.	633 nm, 830 nm 510(k) summary K250966	$469.99 at currentbody.us · Source · Oct 23	Shop at CurrentBody	The 510(k) summary lists 633 and 830 nm; CurrentBody also advertises a 1072 nm deep near-infrared LED.
CurrentBody Skin LED Neck & Dec Perfector	CurrentBody	LED light therapy	No 510(k) on file under this name			415 nm, 532 nm, 590 nm, 633 nm, 830 nm, 1072 nm Maker’s listing	$509.99 at currentbody.us · Source · Oct 23		FDA’s device listing files CurrentBody’s neck devices under the infrared lamp code, with no premarket number. iSMART, one of the listed makers, has a cleared neck device (décoLITE, K242382), but no FDA record names this retail model.
CurrentBody Skin RF	CurrentBody	Radiofrequency	FDA cleared K232424	Mar 6, 2024	Non-invasive treatment of mild to moderate facial wrinkles, adults with Fitzpatrick skin types I-IV.	1 MHz RF, 5 W 510(k) summary K232424	$448.99 at currentbody.us · Source · Oct 23	Shop at CurrentBody
Dr. Dennis Gross DRx SpectraLite EyeCare Pro	Dr. Dennis Gross	LED light therapy	No 510(k) on file under this name Sold as FDA-cleared · Source				$199 at drdennisgross.com · Source · Oct 23		FDA’s device listing names LED Technologies as the maker. Its K171386 covers the dpl SpectraLite. No FDA record names this retail model, which drdennisgross.com calls the EyeCare Max Pro.
Dr. Dennis Gross DRx SpectraLite FaceWare Pro	Dr. Dennis Gross	LED light therapy	No 510(k) on file under this name Sold as FDA-cleared · Source			415 nm, 605 nm, 630 nm, 880 nm Maker’s listing	$455 at drdennisgross.com · Source · Oct 23	Shop at Dermstore	FDA’s device listing names LED Technologies as the maker. Its K183247 covers the dpl Faceware. No FDA record names this retail model.
FOREO BEAR	FOREO	Microcurrent	FDA cleared K200803 FDA record name: BEAR and BEAR mini	Jul 31, 2020	Facial and neck stimulation, over-the-counter cosmetic use.		$329 at foreo.com · Source · Oct 23	Shop at FOREO	On sale for $233.59 on Oct 23, 2026.
FOREO BEAR 2	FOREO	Microcurrent	No 510(k) on file under this name Sold as FDA-cleared · Source			680 µA max Maker’s listing	$399 at foreo.com · Source · Oct 23		The BEAR 2 Body is cleared separately (K232242). FDA’s device listing shows the face BEAR 2 with no premarket number.
FOREO ESPADA	FOREO	Acne light	FDA cleared K162450 FDA record name: ESPADA Acne-Clearing Blue Light Pen	Nov 30, 2016	At-home treatment of mild to moderate inflammatory acne.				Retired model; the maker no longer lists it.
FOREO ESPADA 2	FOREO	Acne light	FDA cleared under another name K162450 FDA record name: ESPADA Acne-Clearing Blue Light Pen	Nov 30, 2016	At-home treatment of mild to moderate inflammatory acne.	415 nm Maker’s listing	$169 at foreo.com · Source · Oct 23	Shop at FOREO	Cleared as ESPADA Acne-Clearing Blue Light Pen. FDA’s device listing puts ESPADA 2 under K162450.
FOREO FAQ 101	FOREO	Radiofrequency	FDA cleared K222012 FDA record name: FAQ 101	Apr 5, 2023	Non-invasive treatment of mild to moderate periorbital wrinkles, adult women with Fitzpatrick skin types I-VI.		$390 at foreo.com · Source · Oct 23	Shop at FOREO
FOREO FAQ 202	FOREO	LED light therapy	FDA cleared K240378 FDA record name: FAQ™ 201, FAQ™ 202	Apr 19, 2024	LED light for the treatment of wrinkles and mild to moderate acne.	440 nm, 465 nm, 485 nm, 520 nm, 580 nm, 600 nm, 650 nm, 850 nm Maker’s listing	$799 at foreo.com · Source · Oct 23	Shop at FOREO	Cleared together with FAQ 201.
HigherDOSE Red Light Face Mask	HigherDOSE	LED light therapy	FDA cleared K241933 FDA record name: HIGHERDOSE Red and Infrared Light Mask (MK66-L)	Sep 27, 2024	Treatment of full-face wrinkles.	630 nm, 830 nm 510(k) summary K241933	$349 at higherdose.com · Source · Oct 23	Shop at HigherDOSE
JOVS Venus Pro II	JOVS	IPL / laser hair removal	No 510(k) on file under this name Sold as FDA-cleared · Source				$429 at jovs.com · Source · Oct 23		The maker, Shenzhen Qianyu, holds IPL clearances (K220645, K214113, K231800). None names the Venus Pro II. On sale for $299 on Oct 23, 2026.
Kenzzi IPL Hair Removal Device	Kenzzi	IPL / laser hair removal	FDA cleared under another name K250253 FDA record name: IPL Hair Removal Device (KCA511/KCA516/KCA522)	May 6, 2025	Removal of unwanted hair; permanent reduction in hair regrowth.	610-1200 nm; 2.18-7.27 J/cm² 510(k) summary K250253	$349 at kenzzi.com · Source · Oct 23		Cleared as IPL Hair Removal Device (KCA511/KCA516/KCA522). FDA’s device listing puts Kenzzi model KCA516 under K250253. On sale for $299 on Oct 23, 2026.
LightStim Elipsa	LightStim	LED light therapy	FDA cleared K212771	Jan 26, 2022	Red and infrared light for full-face wrinkles; blue and red light for mild to moderate inflammatory acne.	410 nm, 612 nm, 645 nm, 655 nm, 850 nm 510(k) summary K212771	$2,495 at lightstim.com · Source · Oct 23	Shop at LightStim
LightStim for Acne	LightStim	Acne light	FDA cleared K261482 FDA record name: LightStim for Wrinkles (1984); LightStim for Acne (2038)	Jul 31, 2026	Treatment of mild to moderate inflammatory acne.	417 nm, 640 nm 510(k) summary K261482	$189 at lightstim.com · Source · Oct 23	Shop at LightStim	One 510(k) covers LightStim for Wrinkles and LightStim for Acne.
LightStim for Wrinkles	LightStim	LED light therapy	FDA cleared K261482 FDA record name: LightStim for Wrinkles (1984); LightStim for Acne (2038)	Jul 31, 2026	Treatment of full-face wrinkles.	605 nm, 640 nm, 652 nm, 850 nm 510(k) summary K261482	$269 at lightstim.com · Source · Oct 23	Shop at LightStim	One 510(k) covers LightStim for Wrinkles and LightStim for Acne.
LYMA Laser PRO	LYMA	LED light therapy	FDA cleared K243330	Feb 21, 2025	Light-based device for treating face wrinkles.	808 nm laser; 620 nm LEDs 510(k) summary K243330	$4,995 at lyma.life · Source · Oct 23
medicube Booster Pro X2	medicube	Microcurrent	No 510(k) on file under this name				$299 at medicube.us · Source · Oct 23		Not in FDA’s device listing either. On sale for $249 on Oct 23, 2026.
MZ Skin LightMAX Supercharged LED Mask 2.0	MZ Skin	LED light therapy	FDA cleared K213184	Nov 23, 2021	Red and blue light for mild to moderate acne vulgaris of the face; red and near-infrared light for full-face wrinkles.	415 nm, 630 nm, 830 nm 510(k) summary K213184	$950 at mzskin.com · Source · Oct 23
NEWA Skin Therapy	NEWA	Radiofrequency	FDA cleared DEN150005 FDA record name: Newa Skin Therapy System	Dec 18, 2015	Non-invasive treatment of mild to moderate facial wrinkles in adult women with Fitzpatrick skin types I-IV.	1 MHz RF De Novo decision summary DEN150005			De Novo, not a 510(k). EndyMed also holds K130793. No current US price.
Nood The Flasher 2.0	Nood	IPL / laser hair removal	FDA cleared under another name K222432 FDA record name: IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439	Oct 11, 2022	Removal of unwanted hair; permanent reduction in hair regrowth.	475-1200 nm; 2.45-5 J/cm² 510(k) summary K222432	$199 at trynood.com · Source · Oct 23		Cleared as IPL Hair Removal Device (KCA423, KCA437, KCA439). FDA’s device listing puts Nood model KCA423 under K222432. Nood lists 510-1200 nm and 4.5 J/cm²; the 510(k) says 475-1200 nm and 2.45-5 J/cm².
NuFACE FIX	NuFACE	Microcurrent	FDA cleared K182424 FDA record name: NuFACE FIX Skin Toning Device	Dec 18, 2018	Facial stimulation, over-the-counter cosmetic use.	200 µA max (at 500 Ω) 510(k) summary K182424			Retired model; the maker no longer lists it.
NuFACE FIX MicroWand	NuFACE	Microcurrent	FDA cleared under another name K240564 FDA record name: NuFACE® FIX+	Jun 27, 2024	Facial stimulation, over-the-counter cosmetic use.	225 µA max 510(k) summary K240564	$175 at mynuface.com · Source · Oct 23	Shop at NuFACE	Cleared as NuFACE FIX+. FDA’s device listing puts the FIX MICROwand under K240564.
NuFACE Mini	NuFACE	Microcurrent	FDA cleared K191672 FDA record name: NuFACE Mini Device	Oct 15, 2019	Facial and neck stimulation, over-the-counter cosmetic use.	348 µA max (at 500 Ω) 510(k) summary K191672			Retired model; the maker no longer lists it.
NuFACE Mini Plus	NuFACE	Microcurrent	FDA cleared K201680	Feb 19, 2021	Facial and neck stimulation, over-the-counter cosmetic use.	335 µA max 510(k) summary K201680	$250 at mynuface.com · Source · Oct 23	Shop at NuFACE
NuFACE Trinity	NuFACE	Microcurrent	FDA cleared K181008	Oct 11, 2018	Facial and neck stimulation, over-the-counter cosmetic use.	400 µA max (at 500 Ω) 510(k) summary K181008			Retired model; the maker no longer lists it.
NuFACE Trinity Plus	NuFACE	Microcurrent	FDA cleared K201782 FDA record name: NuFace Trinity Plus Device	Jan 22, 2021	Facial and neck stimulation, over-the-counter cosmetic use.		$395 at mynuface.com · Source · Oct 23	Shop at NuFACE
Omnilux Clear	Omnilux	Acne light	FDA cleared K210948 FDA record name: Omnilux CLEAR	Jun 24, 2021	Red and blue light to treat mild to moderate acne vulgaris on the face.	412.5 nm, 630 nm 510(k) summary K210948	$395 at omniluxled.com · Source · Oct 23	Shop at Omnilux
Omnilux Contour Face	Omnilux	LED light therapy	FDA cleared under another name K191629 FDA record name: faceLITE	Sep 12, 2019	Treatment of full-face wrinkles.	630 nm, 830 nm 510(k) summary K191629	$395 at omniluxled.com · Source · Oct 23	Shop at Omnilux	Cleared as faceLITE. FDA’s device listing puts Contour Face (model TN19G) under K191629.
Omnilux Contour Neck & Décolleté	Omnilux	LED light therapy	FDA cleared under another name K242382 FDA record name: décoLITE LED Device	Nov 8, 2024	Treatment of wrinkles in the décolletage area.	630 nm, 830 nm 510(k) summary K242382	$395 at omniluxled.com · Source · Oct 23		Cleared as décoLITE LED Device, model TN2037. FDA’s device listing gives the same model number for Contour Neck & Décolleté.
Omnilux Men	Omnilux	LED light therapy	No 510(k) on file under this name Sold as FDA-cleared · Source				$395 at omniluxled.com · Source · Oct 23		FDA’s device listing shows model TN2227 with no premarket number.
Philips Lumea IPL	Philips	IPL / laser hair removal	FDA cleared K243453	Feb 10, 2025	Removal of unwanted hair for a single user; permanent reduction in hair regrowth.				Retired model; the maker no longer lists it.
Philips Lumea IPL 7000 BRI931/03	Philips	IPL / laser hair removal	FDA cleared under another name K243453 FDA record name: Philips Lumea IPL	Feb 10, 2025	Removal of unwanted hair for a single user; permanent reduction in hair regrowth.		$399.95 at usa.philips.com · Source · Oct 23	Shop at Amazon	FDA’s device listing puts model BRI931 under K243453 (Philips Lumea IPL).
Philips Lumea IPL 8000 BRI932/03	Philips	IPL / laser hair removal	FDA cleared under another name K243453 FDA record name: Philips Lumea IPL	Feb 10, 2025	Removal of unwanted hair for a single user; permanent reduction in hair regrowth.		$449.95 at usa.philips.com · Source · Oct 23	Shop at Amazon	FDA’s device listing puts model BRI932 under K243453 (Philips Lumea IPL).
Project E Beauty LumaMask Pro	Project E Beauty	LED light therapy	FDA cleared under another name K214101 FDA record name: Project E Beauty LED Light Therapy Mask (Model: PE730)	Mar 23, 2022	Treatment of full-face wrinkles and mild to moderate acne.	430-445 nm, 635-644 nm, 845-855 nm 510(k) summary K214101	$169 at projectebeauty.com · Source · Oct 23		Cleared as Project E Beauty LED Light Therapy Mask, model PE730, the LumaMask Pro’s SKU. Project E lists blue at 460 nm; the 510(k) says 430-445 nm.
Qure Q-Rejuvalight Pro Facewear	Qure	LED light therapy	FDA cleared K230042 FDA record name: Q-Rejuvalight Pro Facewear (Model: P19-0023)	Apr 28, 2023	Treatment of wrinkles and mild to moderate inflammatory acne.	415 nm, 605 nm, 630 nm, 660 nm, 880 nm 510(k) summary K230042	$399 at qureskincare.com · Source · Oct 23		Model P19-0023 (Light Tree Ventures Europe).
reVive Light Therapy Essentials Acne	reVive Light Therapy	Acne light	FDA cleared K210968 FDA record name: reVive Light Therapy Essentials	Dec 21, 2021	Treatment of mild to moderate inflammatory acne.	415 nm, 630 nm 510(k) summary K210968	$59 at revive-light-therapy.com · Source · Oct 23	Shop at reVive Light Therapy
Shark CryoGlow	Shark	LED light therapy	FDA cleared K242796 FDA record name: CryoGlow	Nov 27, 2024	Red and infrared light for fine lines and wrinkles; red, blue and infrared light for mild to moderate inflammatory acne.	415 nm, 630 nm, 830 nm 510(k) summary K242796	$349.99 at sharkninja.com · Source · Oct 23	Shop at Amazon
Silk'n Infinity	Silk'n	IPL / laser hair removal	FDA cleared K171433	Aug 11, 2017	Removal of unwanted hair; permanent reduction in hair regrowth. Electrical output indicated for facial stimulation (OTC aesthetic use).	475-1200 nm; 3-5 J/cm² (IPL); 420 µA max (microcurrent) 510(k) summary K171433	$419 at silkn.com · Source · Oct 23
SmoothSkin Pure	SmoothSkin	IPL / laser hair removal	FDA cleared K200184	Feb 21, 2020	Removal of unwanted hair; permanent reduction in hair regrowth.				Retired model; the maker no longer lists it.
SmoothSkin Pure Adapt	SmoothSkin	IPL / laser hair removal	FDA cleared K233782 FDA record name: SmoothSkin Pure Adapt (SSG3)	Dec 20, 2023	Removal of unwanted hair; permanent reduction in hair regrowth.	510-1100 nm Maker’s listing	$379 at smoothskin.com · Source · Oct 23	Shop at Amazon	On sale for $249.00 on Oct 23, 2026.
SmoothSkin Pure Fit	SmoothSkin	IPL / laser hair removal	No 510(k) on file under this name				$349 at smoothskin.com · Source · Oct 23	Shop at Amazon	FDA’s device listing shows it with no premarket number. On sale for $199 on Oct 23, 2026.
SmoothSkin Pure Switch	SmoothSkin	IPL / laser hair removal	FDA cleared K243362 FDA record name: SmoothSkin Pure Switch (SSC1)	Nov 27, 2024	Removal of unwanted hair; permanent reduction in hair regrowth.	510-1100 nm (manufacturer); 2-6 J/cm² (510(k) summary K243362) 510(k) summary K243362 + manufacturer spec	$449 at smoothskin.com · Source · Oct 23	Shop at Amazon	On sale for $349.00 on Oct 23, 2026.
Solawave 2-in-1 Skincare Mini	Solawave	LED light therapy	FDA cleared K250532 FDA record name: Solawave 2-in-1 Skincare Mini (Model: 61043)	May 22, 2025	Red and infrared light for wrinkles on the face and décolletage.	630 nm, 830 nm Maker’s listing	$119 at solawave.co · Source · Oct 23	Shop at Solawave
Solawave 4-in-1 Radiant Renewal Skincare Wand	Solawave	LED light therapy	FDA cleared K232863 FDA record name: Radiant Renewal Skincare Wand (HD-15, HD-15A)	Dec 13, 2023	Treatment of wrinkles on the face (HD-15); HD-15A adds facial and neck stimulation for cosmetic use.	630 nm Maker’s listing	$169 at solawave.co · Source · Oct 23	Shop at Solawave	Cleared as Radiant Renewal Skincare Wand (HD-15, HD-15A).
Solawave Bye Acne Spot Treatment	Solawave	Acne light	No 510(k) on file under this name Sold as FDA-cleared · Source			415 nm, 630 nm Maker’s listing	$69 at solawave.co · Source · Oct 23		No Solawave acne device in FDA’s device listing either.
Solawave Wrinkle Retreat Pro Light Therapy Face Mask	Solawave	LED light therapy	No 510(k) on file under this name Sold as FDA-cleared · Source			605 nm, 630 nm, 660 nm, 830 nm Maker’s listing	$499 at solawave.co · Source · Oct 23		FDA’s device listing files it (model PH-m03) under the infrared lamp code, with no premarket number. On sale for $399 on Oct 23, 2026.
Therabody TheraFace LED	Therabody	LED light therapy	FDA cleared K212155 FDA record name: TheraFace LED	Dec 21, 2021	Red and red + IR light for periorbital wrinkles; blue light for mild to moderate inflammatory acne.	415 nm, 633 nm, 830 nm 510(k) summary K212155	$99.99 at therabody.com · Source · Oct 23	Shop at Therabody
Therabody TheraFace Mask	Therabody	LED light therapy	FDA cleared K230293 FDA record name: TheraFace Mask	Jun 9, 2023	Red and red + infrared light for full-face wrinkles; blue light for mild to moderate inflammatory acne.	415 nm, 633 nm, 830 nm 510(k) summary K230293	$649.99 at therabody.com · Source · Oct 23	Shop at Therabody
Therabody TheraFace Microcurrent	Therabody	Microcurrent	FDA cleared K212238 FDA record name: TheraFace Microcurrent	Sep 29, 2021	Facial stimulation, over-the-counter aesthetic use.	500 µA max 510(k) summary K212238	$149.99 at therabody.com · Source · Oct 23	Shop at Therabody
Therabody TheraFace PRO	Therabody	Microcurrent	FDA cleared under another name K212155 · Dec 21, 2021 K212238 · Sep 29, 2021 FDA record name: TheraFace LED; TheraFace Microcurrent	Dec 21, 2021	LED ring: wrinkles and mild to moderate acne (K212155). Microcurrent attachment: facial stimulation, over-the-counter cosmetic use (K212238).	415 nm, 633 nm, 830 nm (LED ring); 500 µA max (microcurrent, K212238) 510(k) summaries K212155; K212238	$419.99 at therabody.com · Source · Oct 23		No 510(k) under the PRO name. FDA’s device listing ties it to the clearances for its LED ring (K212155) and microcurrent attachment (K212238).
Tria Hair Removal Laser 4X	Tria	IPL / laser hair removal	No 510(k) on file under this name Sold as FDA-cleared · Source			810 nm Maker’s listing	$599.99 at trialaser.com · Source · Oct 23	Shop at Tria	Tria’s clearances (K090820, K120737) name the TRIA Laser Hair Removal System, not the 4X.
Tria Hair Removal Laser Precision	Tria	IPL / laser hair removal	No 510(k) on file under this name						Tria’s clearances (K090820, K120737) name the TRIA Laser Hair Removal System only. No current US product page.
TriPollar STOP Vx	TriPollar	Radiofrequency	FDA cleared under another name K203665 FDA record name: STOP U Model UXV Device	Feb 25, 2021	Non-invasive treatment of mild to moderate facial wrinkles, Fitzpatrick skin types II-IV.	1 MHz RF 510(k) summary K203665			The 510(k), K203665, names STOP U Model UXV from Pollogen, TriPollar’s maker. FDA’s device listing ties STOP VX GOLD to the same number. No US price on the maker’s page.
Ulike Air 10	Ulike	IPL / laser hair removal	FDA cleared under another name K241998 FDA record name: Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)	Dec 13, 2024	Removal of unwanted hair; permanent reduction in hair regrowth.	550-1200 nm; 1.67-6.67 J/cm² 510(k) summary K241998	$349 at ulike.com · Source · Oct 23	Shop at Ulike	Cleared as Ice Cooling IPL Hair Removal Device (UI20 models). Ulike's Air 10 manual names these models.
Ulike Air 3	Ulike	IPL / laser hair removal	No 510(k) on file under this name Sold as FDA-cleared · Source				$329 at Ulta Beauty · Source · Oct 23		Ulike holds IPL clearances that name model UI06, such as K233664 and K240652, but the Air3 listing gives no model number. Retired; price from Ulta Beauty.
Ulike Diamond Air+ (UI04A / UI04B / UI04C)	Ulike	IPL / laser hair removal	FDA cleared K221553 FDA record name: Diamond Air+ (UI04A, UI04B, UI04C)	Sep 15, 2022	Removal of unwanted body and/or facial hair; permanent reduction in hair regrowth.		$309 at ulike.com · Source · Oct 23	Shop at Ulike
Ulike ReGlow LED Light Therapy Mask	Ulike	LED light therapy	FDA cleared K243492 FDA record name: Ulike Reglow Light Therapy Device (UM10)	Jan 10, 2025	Treatment of full-face wrinkles and mild to moderate inflammatory acne.	465 nm, 590 nm, 630 nm, 830 nm 510(k) summary K243492	$399 at ulike.com · Source · Oct 23	Shop at Ulike	Model UM10. A second 510(k) for the same model name, K260511, was cleared Mar 16, 2026.
ZIIP HALO	ZIIP	Microcurrent	FDA cleared under another name K212342 FDA record name: ZIIP+ Device	Sep 23, 2021	Facial and neck stimulation, over-the-counter cosmetic use.	309 µA max (at 500 Ω) 510(k) summary K212342	$399.99 at ziipbeauty.com · Source · Oct 23	Shop at CurrentBody	Cleared as ZIIP+ Device. FDA’s device listing puts ZIIP HALO under K212342.
ZIIP+	ZIIP	Microcurrent	FDA cleared K212342 FDA record name: ZIIP+ Device	Sep 23, 2021	Facial and neck stimulation, over-the-counter cosmetic use.	309 µA max (at 500 Ω) 510(k) summary K212342			Retired model; the maker no longer lists it.

Reading the table

“Cleared use” is the use named in the FDA record, shortened. Nothing more is claimed for any device.

“FDA cleared under another name” means the 510(k) uses a different product name, often the factory’s. The notes say which one. GUDID is FDA’s public device listing.

“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. FDA: premarket notification 510(k)

Worth knowing

“No 510(k) on file under this name” doesn’t mean uncleared. It means no FDA record names that product. Brands often sell another company’s cleared device under a new name, and the 510(k) stays under the old one. If a brand says FDA-cleared, ask for the K-number and look it up.

FDA’s device listing has gaps. SmoothSkin Pure Adapt has its own clearance, K233782, yet its GUDID entry shows no premarket number.

Omnilux Men, the Solawave Wrinkle Retreat Pro mask and the CurrentBody Neck & Dec Perfector are listed under FDA’s infrared lamp code. That category doesn’t need a 510(k), and the listing isn’t a clearance for wrinkles or acne.

When a maker’s spec and the 510(k) disagree, the table shows the 510(k) figure and the note gives the maker’s. A blank wavelength or energy cell means neither the FDA filing nor the maker’s page states one. A blank decision date means no FDA record names that product.

Prices are US list prices on the date shown. Sale prices are in the notes. Retired models have no price unless a retailer still lists them.