Cleared Traditional

IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (K250131) - FDA 510(k) Clearance

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

K250131 · Mustech Electronics Co., Limited · General & Plastic Surgery device
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Mar 2025
Decision
61d
Days
Class 2
Risk

K250131 is an FDA 510(k) clearance for the IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M80.... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Mustech Electronics Co., Limited (Shenzhen, CN). The FDA issued a Cleared decision on March 19, 2025 after a review of 61 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 Mustech Electronics Co., Limited devices

Submission Details

510(k) Number K250131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date March 19, 2025
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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

Feiying Drug & Medical Consulting Technical Service Group
Riley Chen

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 K250131.
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
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