Cleared Traditional

K242039 - Ice Cooling IPL Hair Removal Device (UI...

K242039 is the FDA 510(k) clearance for Ice Cooling IPL Hair Removal Device (UI... 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 117-day FDA review.

K242039 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2024
Decision
117d
Days
Class 2
Risk

K242039 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, .... 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 November 6, 2024 after a review of 117 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 K242039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2024
Decision Date November 06, 2024
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
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 K242039.
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
K242710 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Dec 2024
SmoothSkin Pure Switch (SSC1)
K243362 · Cyden Limited · Nov 2024
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
K242595 · Shenzhen Greatro Electronic Technology Co., Ltd. · Nov 2024
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