Cleared Traditional

K802134 - JK INT'L, INC. SOLTRON UVA TANNING BED

K802134 is an FDA 510(k) clearance for JK INT'L, manufactured by Mottek Intl. Corp.. The device is a Class 2 Radiology device with product code LEJ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K802134 · Mottek Intl. Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
49d
Days
Class 2
Risk

K802134 is an FDA 510(k) clearance for the JK INT'L, INC. SOLTRON UVA TANNING BED. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Mottek Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4635 - 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 Mottek Intl. Corp. devices

FDA 510(k) Submission Details - K802134

510(k) Number K802134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1980
Decision Date October 23, 1980
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
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 Radiology devices follow this clearance model.