Shark CryoGlow vs Therabody TheraFace Mask
Last reviewed August 2026.
Short answer: both masks hold an FDA 510(k) clearance we matched in the FDA database — the Shark CryoGlow (FDA 510(k) K242796 (2024), held by SharkNinja Operating, LLC (the brand itself)) and the Therabody TheraFace Mask (FDA 510(k) K230293 (2023), held by Therabody, Inc. (the brand itself)). Only the Therabody TheraFace Mask has a measurement under the cited protocol (19.4 mW/cm²); the Shark CryoGlow has none, so this page does not rank them on light output.
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| Shark CryoGlow | Therabody TheraFace Mask | |
|---|---|---|
| FDA status | Brand-held K — Cleared — the brand holds its own K-number | Brand-held K — Cleared — the brand holds its own K-number |
| 510(k) · holder · decided | K242796 · SharkNinja Operating, LLC · decided 2024-11-27 · device name “CryoGlow (FW3XXXX)” | K230293 · Therabody, Inc. · decided 2023-06-09 · device name “TheraFace Mask” |
| Cleared for | Wrinkles (OHS) · acne per OLP listing | Wrinkles (OHS) · acne per OLP listing |
| Measured irradiance | Not metered under the cited protocol | 19.4 mW/cm² (cited spectrometer test, 29 July 2025) |
| Dose per session | — | 7 J/cm² — 7 J/cm² over the 6-minute red + red/NIR portion of the 9-minute cycle (blue excluded) |
| Wavelengths | 630 nm red · 830 nm infrared · blue (nm as published on page) | 633 + 830 nm (+ 415 nm blue) |
| Treatment time | 6 minutes in Better Aging mode; 8 minutes in Skin Clearing mode; 4 minutes in Skin Sustain mode | 9 minutes, the pre-programmed treatment (three 3-minute light cycles) |
| In the box | CryoGlow LED mask Clip-on chill pads Remote USB-C charging cable | TheraFace Mask device Removable protective eye shields Display stand USB-C charging cable |
| Where to buy | Amazon ↗ sold by Amazon.com, In Stock at our 11 October 2026 read. | No Amazon link: the Amazon US listing B0CNHTST52 had no featured offer at our 11 October 2026 read (only 'See All Buying Options'). |
How to choose
Where one side has no measurement under the cited protocol, do not fill the gap with the brand's own figure or a different tester's: they are not on the same ruler. Compare what is comparable: the clearance and who holds it, the wavelengths, the treatment time and what is in the box. A missing measurement is not a mark against the mask; it is a reason to say “unknown” rather than “less”.
Sources and dates
- Shark CryoGlow: FDA 510(k) record K242796 (read 16 July 2026)
- Shark CryoGlow, treatment time and box contents: sharkninja.com, CryoGlow FW312 product page (read 11 October 2026)
- Therabody TheraFace Mask: FDA 510(k) record K230293 (read 2 October 2026)
- Therabody TheraFace Mask: Light Therapy Insiders spectrometer review (29 July 2025)
- Therabody TheraFace Mask, treatment time and box contents: therabody.com, TheraFace Mask product page (read 11 October 2026)
- Amazon US availability: Amazon US buy box (#desktop_buybox), full page load, delivery address East Hanover 07936; seller ID from #merchantID and the seller= links.
The single-mask pages go deeper: Is the Shark CryoGlow FDA cleared? · Is the Therabody TheraFace Mask FDA cleared? · or see the ranking by measured irradiance and the full clearance record.
LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.
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