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FDA 510(k)

IPL Hair Removal Device

K-Number: K212314 · 2021-10-21

Decision Date2021-10-21
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 Zhongshan Bisen Plastic Electronic Products Co., Ltd.. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K212314. 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 2021-10-21. The listed applicant is Zhongshan Bisen Plastic Electronic Products Co., Ltd.. The 510(k) number is K212314.

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

IPL Hair Removal Device received FDA 510(k) clearance on 2021-10-21, under 510(k) number K212314.

Who is the listed applicant for IPL Hair Removal Device?

The FDA 510(k) record lists Zhongshan Bisen Plastic Electronic Products 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 Zhongshan Bisen Plastic Electronic Products 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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