Cleared Traditional

Home Use Hair Removal Device/T1, T2, T3 (K172883) - FDA 510(k) Clearance

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

K172883 · Shenzhen Mareal Tech Co., Ltd. · General & Plastic Surgery device
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Feb 2018
Decision
144d
Days
Class 2
Risk

K172883 is an FDA 510(k) clearance for the Home Use Hair Removal Device/T1, T2, T3. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Mareal Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 12, 2018 after a review of 144 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 Mareal Tech Co., Ltd. devices

Submission Details

510(k) Number K172883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date February 12, 2018
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
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

Feiying Drug & Medical Consulting Technical Service Group
Rain Yip

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 K172883.
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
Lumilisse IPL Hair Remover
K172791 · Conair Corporation · Jan 2018