Cleared Traditional

K910767 - TL100W/01 UVB LAMP

K910767 is an FDA 510(k) clearance for TL100W/01 UVB LAMP, 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 90-day FDA review.

K910767 · Philips Lighting Co. · General & Plastic Surgery device
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May 1991
Decision
90d
Days
Class 2
Risk

K910767 is an FDA 510(k) clearance for the TL100W/01 UVB LAMP. 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 23, 1991 after a review of 90 days - within the typical 510(k) review window.

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.

View all Philips Lighting Co. devices

FDA 510(k) Submission Details - K910767

510(k) Number K910767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1991
Decision Date May 23, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K910767.
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
PANOSOL II UVA-218
K904426 · National Biological Corp. · Dec 1990
PANOSOL II UVB-206
K904427 · National Biological Corp. · Dec 1990
PANOSOL II UAB-228
K904428 · National Biological Corp. · Dec 1990