Cleared Traditional

K250253 - IPL Hair Removal Device (KCA511/KCA516/...

K250253 is an FDA 510(k) clearance for IPL Hair Removal Device (KCA511/KCA516/..., manufactured by Dongguan Boyuan Intelligent Technology Co.,Ltd. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K250253 · Dongguan Boyuan Intelligent Technology Co.,Ltd · General & Plastic Surgery device
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May 2025
Decision
98d
Days
Class 2
Risk

K250253 is an FDA 510(k) clearance for the IPL Hair Removal Device (KCA511/KCA516/KCA522). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Dongguan Boyuan Intelligent Technology Co.,Ltd (Dongguan, CN). The FDA issued a Cleared decision on May 6, 2025 after a review of 98 days - within the typical 510(k) review window.

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 Dongguan Boyuan Intelligent Technology Co.,Ltd devices

FDA 510(k) Submission Details - K250253

510(k) Number K250253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2025
Decision Date May 06, 2025
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

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 142
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K250253.
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K250131 · Mustech Electronics Co., Limited · Mar 2025
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K250171 · Shenzhen Yang WO Electronic Co., Ltd. · Mar 2025