Cleared Special

K240652 - Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

K240652 is an FDA 510(k) clearance for Ice Cooling IPL Hair Removal Device (UI..., manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Special 510(k) pathway after a 28-day FDA review.

K240652 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 2024

Decision

28d

Days

Class 2

Risk

K240652 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06.... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 4, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K240652

510(k) Number	K240652 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 07, 2024
Decision Date	April 04, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

87d faster than avg

Panel avg: 115d · This submission: 28d

Pathway characteristics

Modification to existing cleared device.

OHT Device Classification - Class 2, Special Controls

Product Code	OHT Light Based Over-the-counter Hair Removal
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHT Light Based Over-the-counter Hair Removal

All 166

Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K240652.

IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

K240969 · Shenzhen Semlamp Intelligent Technology Co., Ltd. · May 2024

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

K241106 · Shenzhen Mlay Intelligent Technology Co., Ltd. · May 2024

IPL Home Use Hair Removal Device (SJ15)

K240093 · Shenzhen Shuge Medical Beauty Devices Co., Ltd. · Apr 2024

IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

K240282 · Dongguan Boyuan Intelligent Technology Co.,Ltd · Apr 2024

SmoothSkin Pure Unplugged (SSB3)

K240587 · Cyden Limited · Mar 2024

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

K240264 · Shenzhen Mlay Intelligent Technology Co., Ltd. · Mar 2024

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.