LightStim

LightStim for Acne

FDA cleared · K261482

$189 Source · 2026-10-22

Where to buy

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What it’s cleared for

LightStim for Acne is an Over-the-Counter device that is intended for the use in the treatment of mild to moderate inflammatory acne.

From the FDA filing (K261482, page 6) — verbatim · retrieved 2026-10-22

Key specs

Light wavelengths: Blue 417 nm, light red 640 nm Source · retrieved 2026-10-22
Suggested use: No more than 3 minutes per area, once daily Source · retrieved 2026-10-22

The FDA record

FDA record K261482 lists the device as “LightStim for Wrinkles (1984); LightStim for Acne (2038)”. The evidence below shows how we matched this exact model.

“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)

K261482 · View FDA record

Device name in the FDA record: LightStim for Wrinkles (1984); LightStim for Acne (2038)
Applicant: Led Intellectual Properties, LLC
Decision date: 2026-07-31
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Evidence: 510(k) record names 'LightStim for Acne'; FDA summary wavelengths 417/640 nm exactly match the manufacturer page 'Blue 417nm, Light Red 640nm'. Source; retrieved 2026-10-22.

Safety notes

Before you use it

Skip light devices if you have a light-sensitive condition such as lupus. Source: American Academy of Dermatology: is red light therapy right for your skin?

Precautions

Wear eye protection if the directions tell you to, using the eye protection that's recommended. Source: American Academy of Dermatology: is red light therapy right for your skin?

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