Cleared Traditional

K241205 - Ice Cooling IPL Hair Removal Device (Y6...

K241205 is the FDA 510(k) clearance for Ice Cooling IPL Hair Removal Device (Y6... by Shenzhen Ulike Smart Electronics Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHT) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K241205 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
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Sep 2024
Decision
132d
Days
Class 2
Risk

K241205 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y.... 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 September 9, 2024 after a review of 132 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Ulike Smart Electronics Co., Ltd. devices

Submission Details

510(k) Number K241205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2024
Decision Date September 09, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 141
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K241205.
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K243030 · Ulike Co., Ltd. · Oct 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · Shenzhen Huaruibo Electric Appliances Co., Ltd. · Oct 2024
IPL Hair Removal Device (BE932C, BE932D, BE932E)
K241834 · Shenzhen Yang WO Electronic Co., Ltd. · Sep 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · Shenzhen Junmei Technology Co., Ltd. · Aug 2024
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
K240016 · Shenzhen Jianrong Biomedical Electronics Co., Ltd. · Jul 2024
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
K241343 · Shenzhen Lescolton Electrical Appliance Co., Ltd. · Jul 2024