Cleared Traditional

K173813 - IPL Hair Removal Device Joy Version (FDA 510(k) Clearance)

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

K173813 · Shen Zhen Cosbeauty Co., Ltd. · General & Plastic Surgery device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 132d · This submission: 266d
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 Peers - OHT Light Based Over-the-counter Hair Removal

All 41
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K173813.
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
K254047 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · Mar 2026
IPL Hair Removal Device (Models: T31A, T32A)
K253666 · Shenzhen Mlay Intelligent Technology Co., Ltd. · Feb 2026
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
K253881 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Dec 2025
Philips Lumea IPL
K253754 · Philips Consumer Lifestyle B.V. · Dec 2025
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