Cleared Traditional

K900693 - U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)

K900693 is an FDA 510(k) clearance for U.V. SUNLAMP (U.V. LIGHT, manufactured by Light Sources, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K900693 · Light Sources, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1990
Decision
42d
Days
Class 2
Risk

K900693 is an FDA 510(k) clearance for the U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC). Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Light Sources, Inc. (Ansonia, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 42 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 - K900693

510(k) Number K900693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date March 27, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 K900693.
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K895410 · Remington Products Company, LLC · Nov 1989
K900693 · U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
Download PDF Light Sources, Inc.