Cleared Traditional

K172181 - micro IPL

K172181 is an FDA 510(k) clearance for micro IPL, manufactured by El Global Trade, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K172181 · El Global Trade, Ltd. · General & Plastic Surgery device
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Oct 2017
Decision
86d
Days
Class 2
Risk

K172181 is an FDA 510(k) clearance for the micro IPL. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on October 13, 2017 after a review of 86 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 El Global Trade, Ltd. devices

FDA 510(k) Submission Details - K172181

510(k) Number K172181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2017
Decision Date October 13, 2017
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 Peers - OHT Light Based Over-the-counter Hair Removal

All 143
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K172181.
Home Use IPL Beauty Device
K180016 · Shenzhen Mismon Technology Co., Ltd. · Mar 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · Shenzhen Mareal Tech Co., Ltd. · Feb 2018
Lumilisse IPL Hair Remover
K172791 · Conair Corporation · Jan 2018
ABC HAIR REMOVAL SYSTEM
K060839 · Palomar Medical Technologies, Inc. · Dec 2006