Cleared Traditional

IPL Hair Removal Device (K183217) - FDA 510(k) Clearance

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

K183217 · Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
88d
Days
Class 2
Risk

K183217 is an FDA 510(k) clearance for the IPL Hair Removal Device. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 15, 2019 after a review of 88 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 Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. devices

Submission Details

510(k) Number K183217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date February 15, 2019
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 Consultant

Guangzhou Keda Testing 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 141
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K183217.
Sensilight Pro / Pistol IPL
K183260 · El Global Trade, Ltd. · Mar 2019
BRAUN Silk.expert Pro 5
K190354 · Cyden Limited · Mar 2019
BRAUN Silk Expert Pro 3
K190366 · Cyden Limited · Mar 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
IPL Hair Removal Device Joy Version
K173813 · Shen Zhen Cosbeauty Co., Ltd. · Sep 2018