Cleared Traditional

K832794 - SUNTANNING BOOTHS AND BEDS

K832794 is an FDA 510(k) clearance for SUNTANNING BOOTHS AND BEDS, manufactured by Tan-N-Trim. The device is a Class 2 Radiology device with product code FTC cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K832794 · Tan-N-Trim · Radiology device
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Jan 1984
Decision
171d
Days
Class 2
Risk

K832794 is an FDA 510(k) clearance for the SUNTANNING BOOTHS AND BEDS. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Tan-N-Trim (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 171 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4630 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tan-N-Trim devices

FDA 510(k) Submission Details - K832794

510(k) Number K832794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date January 27, 1984
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 107d · This submission: 171d
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 Radiology devices follow this clearance model.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 83
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K832794.
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K761187 · National Biological Corp. · Feb 1977