Cleared Traditional

K011197 - DERMACLEAR UV-B PHOTOTHERAPY SYSTEM

K011197 is an FDA 510(k) clearance for DERMACLEAR UV-B PHOTOTHERAPY SYSTEM, manufactured by Lumenis. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K011197 · Lumenis · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
239d
Days
Class 2
Risk

K011197 is an FDA 510(k) clearance for the DERMACLEAR UV-B PHOTOTHERAPY SYSTEM. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Lumenis (Pleasanton, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 239 days - an extended review 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. 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.

FDA 510(k) Submission Details - K011197

510(k) Number K011197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date December 14, 2001
Days to Decision 239 days
Submission Type Traditional
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
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 155
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K011197.
BCLEAR
K020591 · Lumenis · May 2002
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
K021092 · Philips Lighting Co. · May 2002
PHILIPS PLS9W/12/2P UVB
K021514 · Philips Lighting Co. · May 2002
HANDISOL WOUND HEALING
K982082 · National Biological Corp. · Oct 1998
PHOTOTHERAPEUTIX MODEL 2480AB
K935525 · Avex Industries , Ltd. · May 1995
PHOTOTHERAPEUTIX MODEL 800B
K933952 · Avex Industries , Ltd. · Feb 1995
K011197 · DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
Download PDF FDA Summary Lumenis