FDA 510(k)

IPL Hair Removal, Model: OBT-02

K-Number: K213041 · 2021-11-18

Decision Date2021-11-18

Product CodeOHT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal, Model: OBT-02 is a medical device manufactured by Glan Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under approval number K213041. 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, Model: OBT-02?

IPL Hair Removal, Model: OBT-02 is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Glan Electronics Co., Ltd.. The 510(k) number is K213041.

When was IPL Hair Removal, Model: OBT-02 approved by the FDA?

IPL Hair Removal, Model: OBT-02 received FDA 510(k) clearance on 2021-11-18, under approval number K213041.

What company makes IPL Hair Removal, Model: OBT-02?

IPL Hair Removal, Model: OBT-02 is manufactured by Glan Electronics Co., Ltd..

What is the FDA product code for IPL Hair Removal, Model: OBT-02?

The FDA product code for IPL Hair Removal, Model: OBT-02 is OHT.

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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.