Cleared Traditional

K802304 - SOLAR TONE

K802304 is an FDA 510(k) clearance for SOLAR TONE, manufactured by Bloomex International, Inc.. The device is a Class 2 Radiology device with product code LEJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K802304 · Bloomex International, Inc. · Radiology device
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Dec 1980
Decision
69d
Days
Class 2
Risk

K802304 is an FDA 510(k) clearance for the SOLAR TONE. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Bloomex International, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 69 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 Bloomex International, Inc. devices

FDA 510(k) Submission Details - K802304

510(k) Number K802304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date December 01, 1980
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 107d · This submission: 69d
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.

Regulatory Peers - LEJ Booth, Sun Tan

All 13
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