Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CryoGlow (FW3XXXX)

K-Number: K242796 · 2024-11-27

ApplicantSharkninja Operating, LLC
Decision Date2024-11-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoGlow (FW3XXXX) is a medical device manufactured by Sharkninja Operating, LLC. It received FDA 510(k) clearance on 2024-11-27 under approval number K242796. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoGlow (FW3XXXX)?

CryoGlow (FW3XXXX) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Sharkninja Operating, LLC. The 510(k) number is K242796.

When was CryoGlow (FW3XXXX) approved by the FDA?

CryoGlow (FW3XXXX) received FDA 510(k) clearance on 2024-11-27, under approval number K242796.

What company makes CryoGlow (FW3XXXX)?

CryoGlow (FW3XXXX) is manufactured by Sharkninja Operating, LLC.

What is the FDA product code for CryoGlow (FW3XXXX)?

The FDA product code for CryoGlow (FW3XXXX) is OHS.

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑