Cleared Special

K162231 - iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

K162231 is an FDA 510(k) clearance for iPulse SmoothSkin Gold Hair Removal Device, manufactured by Cyden Limited. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Special 510(k) pathway after a 100-day FDA review.

K162231 · Cyden Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
100d
Days
Class 2
Risk

K162231 is an FDA 510(k) clearance for the iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Cyden Limited (Swansea, GB). The FDA issued a Cleared decision on November 16, 2016 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cyden Limited devices

FDA 510(k) Submission Details - K162231

510(k) Number K162231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date November 16, 2016
Days to Decision 100 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 K162231.
PerfectSmooth
K161428 · Shen Zhen Cosbeauty Co., Ltd. · Mar 2017
iPulse SmoothSkin BARE Hair Removal Device
K163552 · Cyden Limited · Mar 2017
Handheld Diode Laser for Hair Removal
K163173 · Liaoning Sidey Optoelectronics Technologies Co., Ltd. · Feb 2017
sensiLight Mini
K161089 · El Global Trade, Ltd. · Jul 2016
iPulse SmoothSkin Gold Hair Removal Device
K160968 · Cyden Limited · Apr 2016
SILKPRO laser hair removal system
K142845 · Wuhan Lotuxs Technology Co., Ltd. · Jul 2015