Products · Red light therapy · Shark (SharkNinja)
Shark CryoGlow LED Face Mask (FW312)
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A home LED mask with an FDA 510(k) clearance (K242796) for fine lines and wrinkles and for mild-to-moderate acne, a 2-year warranty and built-in eye shields. Clearance rests on bench tests, not a clinical trial.
Best for Someone who wants a mask with a verifiable FDA clearance for skin use from a large company with a real warranty, and accepts the price.
- Our quality rating
- Good (4 of 5)
- Price range
- Mid-range
- Verified marks
- FDA 510(k) K242796 (CryoGlow, product codes OHS and OLP)
- Size
- 1.5 lb, 480 LEDs (160 three-color packages), rechargeable lithium-ion batteries
approx. $349 for the FW312 mask (Blue Frost)
See it on Shark (SharkNinja)’s site →We are not affiliated with Shark (SharkNinja). This link goes to the maker’s own page, with no tracking code. How we're funded.
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Your review
Reviews are personal experiences, not research, and they never change our quality ratings. Every review is read by our team before it appears.
How we evaluated it
Why we chose it What put it on our list
- FDA’s 510(k) database lists CryoGlow (K242796, decided 27 November 2024) with product codes OHS and OLP, for two uses: red and infrared light for fine lines and wrinkles, and red, blue and infrared light for mild-to-moderate inflammatory acne.
- The 510(k) summary lists red at 630 nm, blue at 415 nm and infrared at 830 nm (each ±10 nm) from 480 LEDs, and says the mask meets the IEC 62471 photobiological safety standard and IEC 60601-1 electrical standards.
- Silicone eye shields are built in. The summary says the mask shuts off automatically and dims its LEDs when it is taken off the face.
- Shark’s own page gives a 2-year limited warranty, and its returns policy offers a money-back guarantee of 60 or 90 days depending on the product. The FDA filing is in SharkNinja’s own name, not an overseas maker’s or a distributor’s.
Trade-offs What to weigh before you buy
- A 510(k) clearance means FDA found the mask substantially equivalent to one already sold (here, Therabody’s TheraFace mask). The summary lists bench, safety and usability testing and no clinical trial, so it shows the mask is acceptably safe and similar to its predicate, not that it works.
- Shark says the mask is backed by 12-week clinical studies with 60 subjects (fine lines) and 59 subjects (acne). It names no investigator and links no study, so they stay a maker claim.
- It costs about $349. Under-eye cooling, which Shark features, is not one of the cleared uses; the summary says it is for refreshing the skin and does not affect the cleared uses.
- The output figures (in Better Aging mode, 64 mW/cm² red and 64 mW/cm² infrared, 128 mW/cm² in all) are Shark’s numbers in its FDA filing. We found no independent measurement, and nothing is stated about flicker.
What to know Details worth knowing first
Several LED masks hold an FDA 510(k) clearance. That is the strongest regulatory statement available in this category, and it is why we looked at masks. The CryoGlow is listed because its clearance covers two named uses, wrinkles and acne, and because the filing is public, so you can check what was and was not tested.
What a clearance means is narrower than it sounds. FDA decided the mask is substantially equivalent to a mask already on the market, using bench and safety tests. It did not run or require a trial of results here. Our guide to how red light therapy works explains why the mechanism is proposed rather than proven, and the benefits and usage guide covers what the skin research shows.
Masks deliver a fixed program, so you do less dose arithmetic than with a panel. The tradeoffs are price, a battery to charge, and claims on the retail page that go beyond the clearance. Follow the maker’s safety instructions, keep the eye shields in place, and ask a clinician first if you have a skin condition or take medicines that make you sensitive to light.
Quality & testing How it measures up against our checklist
| What we checked | What we found |
|---|---|
| Regulatory status Verified | FDA 510(k) K242796, “CryoGlow (FW3XXXX)”, SharkNinja Operating, LLC, substantially equivalent, decided 27 November 2024. Indications: red and infrared light for the treatment of fine lines and wrinkles; red, blue and infrared light for the treatment of mild-to-moderate inflammatory acne. Over-the-counter use. The model name on Shark’s page (FW312) fits the FW3XXXX pattern in the filing. |
| Measured output Maker’s claim | The 510(k) summary gives power densities by mode, for example 64 mW/cm² red and 64 mW/cm² infrared in the Better Aging mode, set against the predicate. These are the maker’s figures. There is no distance, because the mask sits on the skin. We found no independent measurement. |
| Wavelengths Maker’s claim | Red 630 ±10 nm, blue 415 ±10 nm, infrared 830 ±10 nm, from the 510(k) summary. Shark says bench testing verified the peak of each spectrum. |
| Flicker and eye safety Maker’s claim | Built-in silicone eye shields, automatic shut-off and auto-dimming, and compliance with IEC 62471, all per the 510(k) summary. Flicker is not addressed. |
| Warranty and returns Maker’s claim | Two-year limited warranty on Shark’s site. Its returns policy gives a 60-day or 90-day money-back guarantee “for select products”, and the one that applies is stated with the order, so we could not confirm the term for this mask. |
| Clinical claims Not verified | Shark’s page cites 12-week clinical studies with 60 subjects (Better Aging mode) and 59 subjects (Skin Clearing mode). It names no investigator and links no study. |
| Recall history Verified | We found no FDA device recall for SharkNinja and no CPSC recall for CryoGlow or Shark Beauty (searches on 22 October 2026). SharkNinja has had CPSC recalls of other products, such as 1.8 million Foodi pressure cookers in May 2025. |
What the labels mean
- Verified We opened an independent record that confirms it: a certifier’s listing, a regulator’s list or a lab report. It is linked under Sources.
- Maker’s claim The maker says so on its own page or label. We read it but found no independent record.
- Not verified We looked and could not confirm it, or the maker does not say. Treat it as unknown.
Sources Where our facts come from
- Shark CryoGlow LED Face Mask FW312 product page. Maker’s page. Price, warranty, returns policy, FDA wording and the clinical claims. Open ↗
- FDA 510(k) summary and clearance letter for K242796, CryoGlow (SharkNinja). Certifier or regulator listing. Indications for use, wavelengths, power densities, safety standards and the predicate comparison. Open ↗
- FDA 510(k) database record for K242796 (via openFDA). Certifier or regulator listing. Applicant, decision date and product codes. Data updated 12 October 2026. Open ↗
- FDA device recall database (via openFDA): no SharkNinja entry. Certifier or regulator listing. openFDA answers “No matches found” (shown as an HTTP 404 error) when it holds no record. Open ↗
- CPSC recall search for SharkNinja (saferproducts.gov). Certifier or regulator listing. Lists recalls of other SharkNinja products. A search for CryoGlow returned none. Open ↗
- Amazon listing for the Shark CryoGlow, FW312PL. Independent source. Seen 22 October 2026. Open ↗
- CurrentBody Skin LED Light Therapy Mask Series 2 product page (US). Maker’s page. Source for the alternative: US price and stock status. Open ↗
- FDA 510(k) summary for K250966, CurrentBody Skin LED Light Therapy Mask Series 2. Certifier or regulator listing. Cleared for full-face wrinkles. Lists 633 nm and 830 nm LEDs and no 1072 nm LEDs. Open ↗
- FDA 510(k) summary for K241933, HigherDose Red and Infrared Light Mask. Certifier or regulator listing. Cleared for full-face wrinkles only. Open ↗
Where to buy Other stores and the prices we saw
- Amazon approx. $349. Sold and shipped by Amazon.com when we looked (model FW312PL, a different color).
Prices as we saw them on October 22, 2026. They change often. These links carry no tracking code and earn us nothing.
Alternatives Other options to compare
- CurrentBody Skin LED Light Therapy Mask Series 2 FDA 510(k) K250966, cleared for full-face wrinkles only. About $470 in the US, and out of stock when we looked. The product page lists 16 deep near-infrared LEDs (1072 nm) that the FDA summary does not mention.
- HigherDOSE Red Light Face Mask FDA 510(k) K241933, cleared for full-face wrinkles only. About $349 with a 120-day money-back guarantee, but the product page claims more than the clearance covers.