Cleared Traditional

K873430 - FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12

K873430 is an FDA 510(k) clearance for FAC GE1/HI PERF FAC UPR BODY TE2/FULL B..., manufactured by Klafs Sunlight Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K873430 · Klafs Sunlight Corp. · General & Plastic Surgery device
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Sep 1987
Decision
30d
Days
Class 2
Risk

K873430 is an FDA 510(k) clearance for the FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Klafs Sunlight Corp. (Arlington Heights, US). The FDA issued a Cleared decision on September 25, 1987 after a review of 30 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 Klafs Sunlight Corp. devices

FDA 510(k) Submission Details - K873430

510(k) Number K873430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1987
Decision Date September 25, 1987
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 83
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K873430.
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
HAND/FOOT UVA/UVB 624-224
K872649 · National Biological Corp. · Jul 1987
PANOSOL 2000 624-604
K872650 · National Biological Corp. · Jul 1987
PANOSOL 2000 624-414
K872651 · National Biological Corp. · Jul 1987