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FDA 510(k)

IPL Hair Removal Device

K-Number: K222316 · 2022-09-28

Decision Date2022-09-28
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K222316. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL Hair Removal Device?

IPL Hair Removal Device is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. The 510(k) number is K222316.

When did IPL Hair Removal Device receive FDA 510(k) clearance?

IPL Hair Removal Device received FDA 510(k) clearance on 2022-09-28, under 510(k) number K222316.

Who is the listed applicant for IPL Hair Removal Device?

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

What is the FDA product code for IPL Hair Removal Device?

The FDA product code for IPL Hair Removal Device is OHT.

Other records listing Shenzhen Goodwind Technology Development Co., Ltd. as applicant

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.

Related Devices (Code: OHT)

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.

Official Source

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