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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Accompany Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-24 under 510(k) 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. The listed applicant is Shenzhen Accompany Technology Co., Ltd.. The 510(k) number is K212099.

When did Red Wave Hair Removal receive FDA 510(k) clearance?

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

Who is the listed applicant for Red Wave Hair Removal?

The FDA 510(k) record lists Shenzhen Accompany Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.

Official Source

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

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