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)

Red Wave Hair Removal

K-Number: K212099 · 2021-09-24

ApplicantShenzhen Accompany Technology Co., Ltd.
Decision Date2021-09-24
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Red Wave Hair Removal is a medical device manufactured by Shenzhen Accompany Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-24 under approval number K212099. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Red Wave Hair Removal?

Red Wave Hair Removal is a medical device that received FDA 510(k) clearance on 2021-09-24. It is manufactured by Shenzhen Accompany Technology Co., Ltd.. The 510(k) number is K212099.

When was Red Wave Hair Removal approved by the FDA?

Red Wave Hair Removal received FDA 510(k) clearance on 2021-09-24, under approval number K212099.

What company makes Red Wave Hair Removal?

Red Wave Hair Removal is manufactured by Shenzhen Accompany Technology Co., Ltd..

What is the FDA product code for Red Wave Hair Removal?

The FDA product code for Red Wave Hair Removal is ONF.

Related Devices (Code: ONF)

K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. K160195Forma System, Forma Light SystemFormatk Systems , Ltd. K153717Venus Versa SystemVenus Concept , Ltd. K152790Venus Versa SystemVenus Concept , Ltd. K181868SHINY RPL SystemIds, Ltd.

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.

↑