Cleared Traditional

K852534 - ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9

K852534 is an FDA 510(k) clearance for ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9, manufactured by R. A. Fischer Co. Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K852534 · R. A. Fischer Co. Corp. · General & Plastic Surgery device
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Nov 1985
Decision
147d
Days
Class 2
Risk

K852534 is an FDA 510(k) clearance for the ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by R. A. Fischer Co. Corp. (Glendale, US). The FDA issued a Cleared decision on November 8, 1985 after a review of 147 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.

FDA 510(k) Submission Details - K852534

510(k) Number K852534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date November 08, 1985
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 273
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K852534 · ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
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