Cleared Traditional

K172883 - Home Use Hair Removal Device/T1

K172883 is an FDA 510(k) clearance for Home Use Hair Removal Device/T1, manufactured by Shenzhen Mareal Tech 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 144-day FDA review.

K172883 · Shenzhen Mareal Tech Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172883

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.

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

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 142
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
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Light based hair removal device
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Home Use IPL Beauty Device
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K172791 · Conair Corporation · Jan 2018
ABC HAIR REMOVAL SYSTEM
K060839 · Palomar Medical Technologies, Inc. · Dec 2006