Cleared Traditional

IPL Hair Removal Device (MLY-M011) (K251914) - FDA 510(k) Clearance

Also marketed or referenced as:
IPL Hair Removal Device (MLY-M012) IPL Hair Removal Device (MLY-M013) IPL Hair Removal Device (MLY-M015) IPL Hair Removal Device (MLY-T001) IPL Hair Removal Device (MLY-T002)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251914 · Miley Technology (Hebei) Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
84d
Days
Class 2
Risk

K251914 is an FDA 510(k) clearance for the IPL Hair Removal Device (MLY-M011). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Miley Technology (Hebei) Co., Ltd. (Handan, CN). The FDA issued a Cleared decision on September 15, 2025 after a review of 84 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 Miley Technology (Hebei) Co., Ltd. devices

Submission Details

510(k) Number K251914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2025
Decision Date September 15, 2025
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Caixia Sun

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K251914.
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
K252209 · Foshan Jindi Electric Appliance Co., Ltd. · Oct 2025
IPL Hair Removal Device (IPL-001, IPL-002)
K251398 · Shenzhen Enmind Technology Co., Ltd. · Oct 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG
K252804 · Shenzhen Ulike Smart Electronics Co., Ltd. · Oct 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
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
K251984 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jul 2025