Devices / LED masks & light therapy
Therabody
TheraFace LED
FDA cleared · K212155
“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. What clearance means
What it’s cleared for
The device can work in multiple function modes as following with different indication for use: 1）The red light is intended to treat periorbital wrinkles. 2）The blue light is intended to treat mild to moderate inflammatory acne. 3）The Red + IR is intended to treat periorbital wrinkles.
From the FDA filing (K212155, page 5) — verbatim — not yet human-reviewed · retrieved 2026-10-19
Who should skip it
- Skip it if you have a light-sensitive condition such as lupus. Source: American Academy of Dermatology: is red light therapy right for your skin?
Safety notes
- 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?
The FDA record
Yes — the FDA record names Therabody TheraFace LED.
K212155 · View FDA record
- Device name in the FDA record
- TheraFace LED
- Applicant
- Theragun, Inc.
- Decision date
- 2021-12-21
- Product code
- OHS: Light Based Over The Counter Wrinkle Reduction
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.
Specifications
- Red wavelength
- 633 ± 10 nm · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Blue wavelength
- 415 ± 10 nm · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Infrared wavelength
- 830 ± 10 nm · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Treatment areas (see source for restrictions)
- eye-area · Source — not yet human-reviewed · retrieved 2026-10-19
- Warranty (years)
- 1 · Source — not yet human-reviewed · retrieved 2026-10-19
- Return window (days; conditions apply)
- 30 · Source — not yet human-reviewed · retrieved 2026-10-19
Like-new condition, original packaging/accessories; exclusions for refurbished, personalized, final sale.
Technical details appear only after we’ve checked and cited a source.
Price
USD 99.99 · Source · retrieved 2026-10-20
We verify region, currency, and source date before listing a price.
Where to buy
Affiliate disclosure: we may earn a commission from qualifying purchases through our links. It never changes our pick. As an Amazon Associate I earn from qualifying purchases. How affiliate links work.