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FDA 510(k)

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C

K-Number: K221002 · 2022-06-01

ApplicantShenzhen Ulike Smart Electronics Co., Ltd.
Decision Date2022-06-01
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C is a medical device manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under approval number K221002. 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, Model(s): UI04A, UI04B, UI04C?

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C is a medical device that received FDA 510(k) clearance on 2022-06-01. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K221002.

When was IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C approved by the FDA?

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C received FDA 510(k) clearance on 2022-06-01, under approval number K221002.

What company makes IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C?

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd..

What is the FDA product code for IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C?

The FDA product code for IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C is OHT.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Shenzhen Ulike Smart Electronics Co., Ltd.

K230122IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG K223618IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) K240649Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

View all 22 devices →

Related Devices (Code: OHT)

K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited

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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