Cleared Traditional

K173813 - IPL Hair Removal Device Joy Version

K173813 is an FDA 510(k) clearance for IPL Hair Removal Device Joy Version, manufactured by Shen Zhen Cosbeauty 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 266-day FDA review.

K173813 · Shen Zhen Cosbeauty Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2018
Decision
266d
Days
Class 2
Risk

K173813 is an FDA 510(k) clearance for the IPL Hair Removal Device Joy Version. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shen Zhen Cosbeauty Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2018 after a review of 266 days - an extended review 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: 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 Shen Zhen Cosbeauty Co., Ltd. devices

FDA 510(k) Submission Details - K173813

510(k) Number K173813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2017
Decision Date September 07, 2018
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
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

Sgs-Cstc Standards Technical Services Co., Ltd.
Iris Fung

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 161
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K173813.
IPL Hair Removal Device
K183217 · Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · Feb 2019
Beurer IPL 8500 device/ IPL VelvetSkin Pro
K181734 · Home Well Trading, Ltd. · Sep 2018
IPL Salon Hair Reduction System
K181568 · Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · Sep 2018
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
K181121 · Home Well Trading, Ltd. · Jun 2018
Light based hair removal device
K180383 · Shenzhen Gsd Tech Co., Ltd. · May 2018
Home Use IPL Beauty Device
K180016 · Shenzhen Mismon Technology Co., Ltd. · Mar 2018