Cleared Traditional

K250938 - Ice Cooling IPL Hair Removal Device (MI...

Also marketed or referenced as:
UI04S PP, UI04S BU, UI04S WH, UI04S PN)

K250938 is the FDA 510(k) clearance for Ice Cooling IPL Hair Removal Device (MI... 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 56-day FDA review.

K250938 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
56d
Days
Class 2
Risk

K250938 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01.... 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 May 23, 2025 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K250938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2025
Decision Date May 23, 2025
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K250938.
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
K251000 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · Jun 2025
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
K243036 · Bestway Plastic and Metal Products , Ltd. · Jun 2025
IPL400
K250384 · El Global Trade, Ltd. · May 2025
IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
K243017 · Foshan Newface Electronic Technology Co., Ltd. · May 2025
IPL Hair Removal Device (KCA511/KCA516/KCA522)
K250253 · Dongguan Boyuan Intelligent Technology Co.,Ltd · May 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K250194 · Shenzhen Ulike Smart Electronics Co., Ltd. · Mar 2025