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FDA 510(k)

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)

K-Number: K252618 · 2025-11-14

ApplicantAlovea Healthcare Co. , Ltd.
Decision Date2025-11-14
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) is a medical device manufactured by Alovea Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2025-11-14 under approval number K252618. 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 (I6 S1, I6 D1, I6 M1)?

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by Alovea Healthcare Co. , Ltd.. The 510(k) number is K252618.

When was IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) approved by the FDA?

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) received FDA 510(k) clearance on 2025-11-14, under approval number K252618.

What company makes IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)?

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) is manufactured by Alovea Healthcare Co. , Ltd..

What is the FDA product code for IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)?

The FDA product code for IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) 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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