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FDA 510(k)

Ice 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)

K-Number: K240649 · 2024-06-21

ApplicantShenzhen Ulike Smart Electronics Co., Ltd.
Decision Date2024-06-21
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ice 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) is a medical device manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-06-21 under approval number K240649. 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 Ice 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)?

Ice 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) is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K240649.

When was Ice 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) approved by the FDA?

Ice 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) received FDA 510(k) clearance on 2024-06-21, under approval number K240649.

What company makes Ice 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)?

Ice 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) is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd..

What is the FDA product code for Ice 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)?

The FDA product code for Ice 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) is OHT.

Related Clinical Trials

NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT06430268 Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants ENROLLING_BY_INVITATION NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT05901038 Development of Artefact Removal and Physical Activity Algorithm COMPLETED

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

K221002IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C 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)

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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