Cleared Special

K061295 - VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

K061295 is an FDA 510(k) clearance for VERSACLEAR SKIN THERAPY SYSTEM, manufactured by Theralight, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Special 510(k) pathway after a 16-day FDA review.

K061295 · Theralight, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
16d
Days
Class 2
Risk

K061295 is an FDA 510(k) clearance for the VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Theralight, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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.

FDA 510(k) Submission Details - K061295

510(k) Number K061295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2006
Decision Date May 25, 2006
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 183
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K061295.
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K061295 · VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
Download PDF FDA Summary Theralight, Inc.