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FDA 510(k)

IPL Hair Removal Device

K-Number: K212314 · 2021-10-21

ApplicantZhongshan Bisen Plastic Electronic Products Co., Ltd.
Decision Date2021-10-21
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device is a medical device manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd.. It received FDA 510(k) clearance on 2021-10-21 under approval 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. It is manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd.. The 510(k) number is K212314.

When was IPL Hair Removal Device approved by the FDA?

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

What company makes IPL Hair Removal Device?

IPL Hair Removal Device is manufactured by Zhongshan Bisen Plastic Electronic Products Co., Ltd..

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

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

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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.

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