Devices / LED masks & light therapy

FOREO FAQ 202 LED light therapy device

FOREO

FAQ 202

FDA cleared · K240378

$799 at FOREO Source · Oct 23

Where to buy

What it’s cleared for

FAQ™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.

FDA filing K240378, p. 4

Key specs

Light wavelengths
Near-infrared 850 nm, red 650 nm and blue 465 nm Source · Oct 23
Other colors
Green, orange, yellow, purple and cyan. FOREO says these five are not intended to have a medical effect. Source · Oct 23
LED count
600 LED points Source · Oct 23
Session length
5 to 15 minutes, 3 to 5 times a week Source · Oct 23
Battery
Up to 90 minutes per charge, USB Source · Oct 23
Weight
169 g Source · Oct 23
Build
Flexible silicone with open eyes and mouth. Not waterproof, so no rinsing under the tap. Source · Oct 23
Areas
Face Source · Oct 23
Cordless
Yes Source · Oct 23
App needed
Yes Source · Oct 23
Needs the app once to activate, then works without it.
Warranty
2 years Source · Oct 23
Returns
14 days Source · Oct 19
Unopened only.

The FDA record

FDA record K240378 lists the device as “FAQ™ 201, FAQ™ 202”.

“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)

K240378 · View FDA record

Device name in the FDA record
FAQ™ 201, FAQ™ 202
Applicant
Foreo, Inc.
Decision date
2024-04-19
FDA category name
Light Based Over The Counter Wrinkle Reduction (OHS)
Safety notes

Before you use it

Precautions

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