Cleared Traditional

K935840 - TL 20W/12/RS & TL 40W/12/RS

K935840 is an FDA 510(k) clearance for TL 20W/12/RS & TL 40W/12/RS, 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 79-day FDA review.

K935840 · Philips Lighting Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
79d
Days
Class 2
Risk

K935840 is an FDA 510(k) clearance for the TL 20W/12/RS & TL 40W/12/RS. 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 February 24, 1994 after a review of 79 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.

View all Philips Lighting Co. devices

FDA 510(k) Submission Details - K935840

510(k) Number K935840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date February 24, 1994
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 66
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K935840.
HOUVA 3 PHOTOTHERAPY SYSTEM
K041212 · National Biological Corp. · Jun 2004
BCLEAR
K021762 · Lumenis, Inc. · Aug 2002
HANDISOL WOUND HEALING
K982082 · National Biological Corp. · Oct 1998
UVISOL AND UVISOL II
K934808 · National Biological Corp. · Dec 1993
PHOTOTHERAPY TIMER
K924969 · National Biological Corp. · Feb 1993
HANDISOL
K924077 · National Biological Corp. · Nov 1992