Class Class II

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (K250942)

K250942 2025-07-11 Traditional
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Description

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) by Shenzhen Ulike Smart Electronics Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250942
Clearance Date2025-07-11
Clearance TypeTraditional
Product CodeOHT
Regulation Number878.4810

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Predicate lineage for K250942

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 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (K250942) cites 4 predicate devices and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20...Shenzhen Ulike Smart Electronics Co...2024
K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electr...2024
K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Mo...Shenzhen Ionka Medical Technology C...2023
K130315IPULSE HAIR REMOVAL SYSTEMCyden Limited2013

Later devices that cite this one as their predicate

Devices that cite K250942
K numberDeviceApplicantYear
K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, ...Shenzhen Chuangtong Yigou Technolog...2026
K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technolog...2026

Trace the full predicate network for K250942

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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