Cleared Traditional

K241998 - Ice Cooling IPL Hair Removal Device (UI...

K241998 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 157-day FDA review.

K241998 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
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Dec 2024
Decision
157d
Days
Class 2
Risk

K241998 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20.... 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 December 13, 2024 after a review of 157 days - an extended review 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. 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 K241998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2024
Decision Date December 13, 2024
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 K241998.
IPL Hair Removal Device (BE965A, BE965B, BE965C)
K250171 · Shenzhen Yang WO Electronic Co., Ltd. · Mar 2025
Philips Lumea IPL
K243453 · Philips Consumer Lifestyle B.V. · Feb 2025
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
K243085 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Dec 2024
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