Devices / LED masks & light therapy

Shark CryoGlow LED light therapy device

Shark

CryoGlow

FDA cleared · K242796

$349.99 at SharkNinja Source · Oct 21

Where to buy

What it’s cleared for

The CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.

FDA filing K242796, p. 4

Key specs

LED light colors
Red, Blue, Deep Infrared LEDs Source · Oct 21
Routines
4 routines Source · Oct 21
Under-eye cooling levels
3 temperature-controlled chill levels (InstaChill Cold Technology) Source · Oct 21
Weight
1.5 lbs Source · Oct 21
Warranty
2 years Source · Oct 21
Dimensions
7.99 in L x 5.51 in W x 8.62 in H Source · Oct 21
Power
7.2 volts, 16.92 watts (35 watts peak), 5.8 amps Source · Oct 21
Areas
Face Source · Oct 19
Returns
60 days Source · Oct 19

The FDA record

FDA record K242796 lists the device as “CryoGlow”.

“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)

K242796 · View FDA record

Device name in the FDA record
CryoGlow
Applicant
Sharkninja Operating, LLC
Decision date
2024-11-27
FDA category name
Light Based Over The Counter Wrinkle Reduction (OHS)
Safety notes

Before you use it

Precautions

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