Cleared Traditional

K832482 - COMBO UVB/UVA TANNING BOOTHS 8-40-12-36 (FDA 510(k) Clearance)

K832482 · Sun Shanty, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
281d
Days
-
Risk

K832482 is an FDA 510(k) clearance for the COMBO UVB/UVA TANNING BOOTHS 8-40-12-36.

Submitted by Sun Shanty, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 281 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Sun Shanty, Inc. devices

Submission Details

510(k) Number K832482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date April 24, 1984
Days to Decision 281 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
167d slower than avg
Panel avg: 114d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -