510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242796Substantially Equivalent

CryoGlow (FW3XXXX)

Sharkninja Operating LLC, Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242796 is the FDA 510(k) clearance record for CryoGlow (FW3XXXX), a class II device, cleared for Sharkninja Operating, LLC on under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction). FDA's definition for product code OHS reads: "Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided". FDA records list one 510(k) clearance for Sharkninja Operating, LLC. As of , FDA records show no recalls naming K242796.

Clearance record

Decision date
Received
(72 days to decision)
Product code
OHS Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sharkninja Operating, LLC 89 A St., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHS

Trailing 12 months
35 clearances under product code OHS in the twelve months to October 2026, December 2025 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code OHS, trailing twelve months
MonthClearances
November 20253
December 20258
January 20263
February 20262
March 20264
April 20261
May 20261
June 20264
July 20264
August 20265
September 20260
October 20260