Cleared Traditional

K800160 - SUN-TANNING BOOTHS

K800160 is an FDA 510(k) clearance for SUN-TANNING BOOTHS, manufactured by World Wide Sun Systems, Inc.. The device is a Class 2 Radiology device with product code FTC cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K800160 · World Wide Sun Systems, Inc. · Radiology device
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Mar 1980
Decision
39d
Days
Class 2
Risk

K800160 is an FDA 510(k) clearance for the SUN-TANNING BOOTHS. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by World Wide Sun Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 39 days - a notably fast clearance 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: 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 World Wide Sun Systems, Inc. devices

FDA 510(k) Submission Details - K800160

510(k) Number K800160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1980
Decision Date March 03, 1980
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
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
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