Cleared Traditional

K211174 - IPL Hair Removal

K211174 is an FDA 510(k) clearance for IPL Hair Removal, 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 134-day FDA review.

K211174 · Shenzhen Qiaochengli Technology Co., Ltd. · General & Plastic Surgery device
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Sep 2021
Decision
134d
Days
Class 2
Risk

K211174 is an FDA 510(k) clearance for the IPL Hair Removal. 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 September 1, 2021 after a review of 134 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 Shenzhen Qiaochengli Technology Co., Ltd. devices

FDA 510(k) Submission Details - K211174

510(k) Number K211174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2021
Decision Date September 01, 2021
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
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

Guangzhou Keda Biological Tech Co., Ltd.
Jet Li

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 K211174.
IPL Hair Removal Device
K212314 · Zhongshan Bisen Plastic Electronic Products Co., Ltd. · Oct 2021
Superior Hair Remover
K210376 · Guangzhou Haoxingwan Technology Co., Ltd. · Oct 2021
IPL Home Use Hair Removal Device
K211922 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · Sep 2021
Braun Silk.expert Mini
K211994 · Cyden Limited · Jul 2021
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
K210311 · Shenzhen Mismon Technology Co., Ltd. · Jul 2021
IPL Hair removal
K203510 · Shenzhen Weikai Technology Co.,Ltd · Feb 2021