Cleared Traditional

K872649 - HAND/FOOT UVA/UVB 624-224

K872649 is an FDA 510(k) clearance for HAND/FOOT UVA/UVB 624-224, manufactured by National Biological Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K872649 · National Biological Corp. · General & Plastic Surgery device
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Jul 1987
Decision
20d
Days
Class 2
Risk

K872649 is an FDA 510(k) clearance for the HAND/FOOT UVA/UVB 624-224. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by National Biological Corp. (Twinsburg, US). The FDA issued a Cleared decision on July 27, 1987 after a review of 20 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.

View all National Biological Corp. devices

FDA 510(k) Submission Details - K872649

510(k) Number K872649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date July 27, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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 51
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K872649.
HOUVA II UVA/UVB
K885029 · National Biological Corp. · Jun 1989
HOUVA II UVA
K885025 · National Biological Corp. · Jan 1989
HOUVA-BED
K882722 · National Biological Corp. · Aug 1988
PANOSOL 2000 624-604
K872650 · National Biological Corp. · Jul 1987
PANOSOL 2000 624-414
K872651 · National Biological Corp. · Jul 1987
PANOSOL 2000 624-616
K872706 · National Biological Corp. · Jul 1987