FDA 510(k)

Diamond Air+ (UI04A, UI04B, UI04C)

K-Number: K221553 · 2022-09-15

Decision Date2022-09-15

Product CodeOHT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Diamond Air+ (UI04A, UI04B, UI04C) is a medical device manufactured by Ulike Co., Ltd.. It received FDA 510(k) clearance on 2022-09-15 under approval number K221553. 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 Diamond Air+ (UI04A, UI04B, UI04C)?

Diamond Air+ (UI04A, UI04B, UI04C) is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Ulike Co., Ltd.. The 510(k) number is K221553.

When was Diamond Air+ (UI04A, UI04B, UI04C) approved by the FDA?

Diamond Air+ (UI04A, UI04B, UI04C) received FDA 510(k) clearance on 2022-09-15, under approval number K221553.

What company makes Diamond Air+ (UI04A, UI04B, UI04C)?

Diamond Air+ (UI04A, UI04B, UI04C) is manufactured by Ulike Co., Ltd..

What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C)?

The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C) is OHT.

Other Devices by Ulike Co., Ltd.

K213558IPL Hair Removal Device K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)

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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.