Cleared Traditional

K103184 - SILK'N FLASH N GO

K103184 is an FDA 510(k) clearance for SILK'N FLASH N GO, manufactured by Home Skinovations , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K103184 · Home Skinovations , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
12d
Days
Class 2
Risk

K103184 is an FDA 510(k) clearance for the SILK'N FLASH N GO. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Home Skinovations , Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on November 10, 2010 after a review of 12 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 Home Skinovations , Ltd. devices

FDA 510(k) Submission Details - K103184

510(k) Number K103184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2010
Decision Date November 10, 2010
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
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 K103184.
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