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FDA 510(k)

IPL Hair Removal Device (IPL-001, IPL-002)

K-Number: K251398 · 2025-10-02

ApplicantShenzhen Enmind Technology Co., Ltd.
Decision Date2025-10-02
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (IPL-001, IPL-002) is a medical device manufactured by Shenzhen Enmind Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under approval number K251398. 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-001, IPL-002)?

IPL Hair Removal Device (IPL-001, IPL-002) is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Shenzhen Enmind Technology Co., Ltd.. The 510(k) number is K251398.

When was IPL Hair Removal Device (IPL-001, IPL-002) approved by the FDA?

IPL Hair Removal Device (IPL-001, IPL-002) received FDA 510(k) clearance on 2025-10-02, under approval number K251398.

What company makes IPL Hair Removal Device (IPL-001, IPL-002)?

IPL Hair Removal Device (IPL-001, IPL-002) is manufactured by Shenzhen Enmind Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device (IPL-001, IPL-002)?

The FDA product code for IPL Hair Removal Device (IPL-001, IPL-002) 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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