Cleared Traditional

K021514 - PHILIPS PLS9W/12/2P UVB

K021514 is an FDA 510(k) clearance for PHILIPS PLS9W/12/2P UVB, manufactured by Philips Lighting Co.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K021514 · Philips Lighting Co. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
7d
Days
Class 2
Risk

K021514 is an FDA 510(k) clearance for the PHILIPS PLS9W/12/2P UVB. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Philips Lighting Co. (Somerset, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 7 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. 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.

FDA 510(k) Submission Details - K021514

510(k) Number K021514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date May 16, 2002
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
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 269
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K021514.
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
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K021092 · Philips Lighting Co. · May 2002
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K011197 · Lumenis · Dec 2001
HANDISOL WOUND HEALING
K982082 · National Biological Corp. · Oct 1998
PHOTOTHERAPEUTIX MODEL 2480AB
K935525 · Avex Industries , Ltd. · May 1995
K021514 · PHILIPS PLS9W/12/2P UVB
Download PDF FDA Summary Philips Lighting Co.