Cleared Special

K251984 - Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

K251984 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 27-day FDA review.

K251984 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
27d
Days
Class 2
Risk

K251984 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,.... 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 July 24, 2025 after a review of 27 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 - K251984

510(k) Number K251984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2025
Decision Date July 24, 2025
Days to Decision 27 days
Submission Type Special
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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 K251984.
IPL Hair Removal Device (MLY-M011)
K251914 · Miley Technology (Hebei) Co., Ltd. · Sep 2025
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
K251176 · Shenzhen Mlay Intelligent Technology Co., Ltd. · Aug 2025
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
K251707 · Shenzhen Huachuangtong Industrial Co., Ltd. · Aug 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
K251173 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Jul 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
K250942 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jul 2025
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
K251984 · Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Download PDF FDA Summary Shenzhen Ulike Smart …