Cleared Traditional

K936314 - ODYSSEY TAN 2000

K936314 is an FDA 510(k) clearance for ODYSSEY TAN 2000, manufactured by Fitness TO Go, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K936314 · Fitness TO Go, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
214d
Days
Class 2
Risk

K936314 is an FDA 510(k) clearance for the ODYSSEY TAN 2000. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Fitness TO Go, Inc. (Lees Summit, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 214 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4635 - 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.

View all Fitness TO Go, Inc. devices

FDA 510(k) Submission Details - K936314

510(k) Number K936314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date July 22, 1994
Days to Decision 214 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 115d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEJ Device Classification - Class 2, Special Controls

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
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.