Cleared Traditional

K143003 - iPulse Smooth Skin Gold Hair Removal System

K143003 is an FDA 510(k) clearance for iPulse Smooth Skin Gold Hair Removal System, manufactured by Ipulse Limited. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K143003 · Ipulse Limited · General & Plastic Surgery device
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Jun 2015
Decision
241d
Days
Class 2
Risk

K143003 is an FDA 510(k) clearance for the iPulse Smooth Skin Gold Hair Removal System. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Ipulse Limited (Swansea, GB). The FDA issued a Cleared decision on June 18, 2015 after a review of 241 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 Ipulse Limited devices

FDA 510(k) Submission Details - K143003

510(k) Number K143003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date June 18, 2015
Days to Decision 241 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
126d slower than avg
Panel avg: 115d · This submission: 241d
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 148
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K143003.
iPulse SmoothSkin BARE Hair Removal Device
K163552 · Cyden Limited · Mar 2017
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
K162231 · Cyden Limited · Nov 2016
iPulse SmoothSkin Gold Hair Removal Device
K160968 · Cyden Limited · Apr 2016
IPULSE HAIR REMOVAL SYSTEM
K130315 · Cyden Limited · Jul 2013
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
K122280 · Cyden Limited · Oct 2012
ABC HAIR REMOVAL SYSTEM
K060839 · Palomar Medical Technologies, Inc. · Dec 2006