Class Class II

Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (K250938)

K250938 2025-05-23 Traditional
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Description

Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) by Shenzhen Ulike Smart Electronics Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250938
Clearance Date2025-05-23
Clearance TypeTraditional
Product CodeOHT
Regulation Number878.4810

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Predicate lineage for K250938

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (K250938) cites 3 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UI...Shenzhen Ulike Smart Electronics Co...2024
K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electr...2024
K130315IPULSE HAIR REMOVAL SYSTEMCyden Limited2013

Later devices that cite this one as their predicate

Devices that cite K250938
K numberDeviceApplicantYear
K250384IPL400El Global Trade, Ltd.2025

Trace the full predicate network for K250938

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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