Cleared Traditional

K252234 - IPL Home Use Hair Removal Device (Model...

K252234 is an FDA 510(k) clearance for IPL Home Use Hair Removal Device (Model..., manufactured by Shenzhen Qiaochengli 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 89-day FDA review.

K252234 · Shenzhen Qiaochengli Technology Co., Ltd. · General & Plastic Surgery device
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Oct 2025
Decision
89d
Days
Class 2
Risk

K252234 is an FDA 510(k) clearance for the IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, .... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Qiaochengli Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 14, 2025 after a review of 89 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 Qiaochengli Technology Co., Ltd. devices

FDA 510(k) Submission Details - K252234

510(k) Number K252234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2025
Decision Date October 14, 2025
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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

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 142
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K252234.
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
K253304 · Dongguan Lide Electric Appliance Co., Ltd. · Nov 2025
IPL Hair Removal Device (SYL001AZ, SYL002AZ)
K253035 · Gu'An Yeolight Smart Electronics Co., Ltd. · Nov 2025
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
K252618 · Alovea Healthcare Co. , Ltd. · Nov 2025
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