Yes. The Shark CryoGlow LED face mask is FDA-cleared under 510(k) number K242796 — listed in the FDA database with applicant "Sharkninja Operating, LLC," device name "CryoGlow (FW3XXXX)," and an FDA decision date of November 27, 2024. If a brand claims FDA clearance, this is exactly the kind of database entry you should expect to find.
How to verify it yourself (2 minutes)
- Go to the FDA 510(k) database at accessdata.fda.gov (Scripts → 510(k) Premarket Notification database).
- Search K242796 — not the brand name. FDA records list the manufacturer/applicant and model numbers, so the K number is the reliable key.
- Confirm the three fields: applicant "Sharkninja Operating, LLC," device "CryoGlow (FW3XXXX)," decision date November 27, 2024.
This same method works for any LED mask. (For reference, Photira's clearance is K254007 — applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, and KKS-281.)
What "FDA-cleared" means here
"FDA-cleared" (via the 510(k) pathway) means the FDA reviewed the device and found it substantially equivalent to a legally marketed predicate device. It is not the same as "FDA-approved," which refers to the more extensive PMA review used for higher-risk devices. Shark's own site describes the CryoGlow as "clinically tested & FDA-cleared."
Price and warranty context (as of October 7, 2026)
On sharkninja.com, the CryoGlow is listed at $299.99 (list price $349.99) with a two (2) year limited warranty. Note that Shark has not published wavelength values in nanometers for the CryoGlow, so any article quoting specific nm numbers for it is guessing — compare on that basis with care.
Frequently asked questions
What is the Shark CryoGlow's 510(k) number?
K242796. In the FDA database it appears under applicant "Sharkninja Operating, LLC" with the device name "CryoGlow (FW3XXXX)" and a decision date of November 27, 2024.
Does FDA-cleared mean the same as FDA-approved?
No. Clearance through the 510(k) pathway means the FDA found the device substantially equivalent to a predicate device. Approval (PMA) is a separate, more extensive review for higher-risk devices. Marketers sometimes blur the two — the database entry tells you which one applies.
What is the CryoGlow cleared for?
Shark describes the CryoGlow as targeting fine lines, firmness, acne, and redness, with programmed treatments (Better Aging, Skin Clearing, Skin Sustain, Under-Eye Revive). For the exact cleared indications, check the 510(k) summary for K242796 in the FDA database.
How much does the Shark CryoGlow cost?
$299.99 (list $349.99) on sharkninja.com as of October 7, 2026, with a two-year limited warranty. Amazon pricing could not be verified at check time.
How can I check any LED mask's FDA clearance myself?
Search the FDA 510(k) database by K number at accessdata.fda.gov and match the applicant, device/model name, and decision date. If a brand claims clearance but you can't find a K number, ask the brand for it — legitimate clearances are public records.