Cleared Special

K131870 - GLIDE DEVICE

K131870 is an FDA 510(k) clearance for GLIDE DEVICE, manufactured by Home Skinovations , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Special 510(k) pathway after a 51-day FDA review.

K131870 · Home Skinovations , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
51d
Days
Class 2
Risk

K131870 is an FDA 510(k) clearance for the GLIDE DEVICE. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Home Skinovations , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on August 14, 2013 after a review of 51 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Home Skinovations , Ltd. devices

FDA 510(k) Submission Details - K131870

510(k) Number K131870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2013
Decision Date August 14, 2013
Days to Decision 51 days
Submission Type Special
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
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K131870.
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
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IPULSE HAIR REMOVAL SYSTEM
K130315 · Cyden Limited · Jul 2013
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
K122280 · Cyden Limited · Oct 2012
SILK'N FLASH N GO
K103184 · Home Skinovations , Ltd. · Nov 2010