Cleared Traditional

K140381 - SENSILIGHT/ SENSILIGHT PLUS

K140381 is an FDA 510(k) clearance for SENSILIGHT/ SENSILIGHT PLUS, 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 175-day FDA review.

K140381 · El Global Trade, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
175d
Days
Class 2
Risk

K140381 is an FDA 510(k) clearance for the SENSILIGHT/ SENSILIGHT PLUS. 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 August 8, 2014 after a review of 175 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.

View all El Global Trade, Ltd. devices

FDA 510(k) Submission Details - K140381

510(k) Number K140381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date August 08, 2014
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
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 165
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K140381.
iPulse Smooth Skin Gold Hair Removal System
K143003 · Ipulse Limited · Jun 2015
GLIDE DEVICE
K141242 · Home Skinovations , Ltd. · Oct 2014
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
K132518 · Wellquest Intl., Inc. · Aug 2014
SENSILIGHT MINI
K140527 · El Global Trade, Ltd. · Jul 2014
GLIDE DEVICE
K131870 · Home Skinovations , Ltd. · Aug 2013
IPULSE HAIR REMOVAL SYSTEM
K130315 · Cyden Limited · Jul 2013