Cleared Traditional

K854498 - SPECTRA 724

K854498 is an FDA 510(k) clearance for SPECTRA 724, manufactured by Daavlin Co.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K854498 · Daavlin Co. · General & Plastic Surgery device
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Nov 1985
Decision
13d
Days
Class 2
Risk

K854498 is an FDA 510(k) clearance for the SPECTRA 724. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Daavlin Co. (Bryan, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K854498

510(k) Number K854498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date November 25, 1985
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 184
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K854498.
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KRYPTOSOL (SUN LAMP)
K860117 · Trademark Imports · Jan 1986
FOLDALITE UNIT
K827890 · National Biological Corp. · Aug 1982
SPECTRA305
K820492 · Ultralite · Mar 1982
METEC HELARIUM LOUNGE & SKY UNITS
K812225 · Klafs Sunlight Corp. · Mar 1982
K854498 · SPECTRA 724
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