Devices / LED masks & light therapy
Therabody
TheraFace Mask
FDA cleared · K230293
“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
'Red Light is intended to treat full face wrinkles *Blue Light is intended to treat mild to moderate inflammatory acne *Red + Infrared Light is intended to treat full face wrinkles
From the FDA filing (K230293, page 3) — 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 Mask.
K230293 · View FDA record
- Device name in the FDA record
- TheraFace Mask
- Applicant
- Therabody, Inc.
- Decision date
- 2023-06-09
- 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 5 · retrieved 2026-10-19
- Blue wavelength
- 415 ± 10 nm · From FDA filing — not yet human-reviewed · page 5 · retrieved 2026-10-19
- Infrared wavelength
- 830 ± 10 nm · From FDA filing — not yet human-reviewed · page 5 · retrieved 2026-10-19
- Red irradiance
- 73 ± 5 mW/cm² · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Blue irradiance
- 64 ± 5 mW/cm² · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Red fluence
- 13.14 ± 0.9 J/cm² · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Blue fluence
- 11.52 ± 0.9 J/cm² · From FDA filing — not yet human-reviewed · page 7 · retrieved 2026-10-19
- Treatment areas (see source for restrictions)
- face · Source — not yet human-reviewed · retrieved 2026-10-19
- Coded cautions (read full instructions)
- open-wound, pregnancy, epilepsy, photosensitive, melasma · Source — not yet human-reviewed · retrieved 2026-10-19
Manufacturer contraindications section advises professional consultation before use. Conservatively gated; vibration-only cautions not transferred to LED. Additional conditions not expressible in enum remain in source. - Session minutes (see source for treatment area)
- 9 · Source — not yet human-reviewed · retrieved 2026-10-19
- Cordless
- Yes · 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 649.99 · Source · retrieved 2026-10-20
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Where to buy
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