Cleared Traditional

K881385 - PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL

K881385 is an FDA 510(k) clearance for PSORALITE PHOTOTHERAPY TREATMENT BOOTH/..., manufactured by Psoralite Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K881385 · Psoralite Corp. · General & Plastic Surgery device
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Apr 1988
Decision
9d
Days
Class 2
Risk

K881385 is an FDA 510(k) clearance for the PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Psoralite Corp. (Columbia, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 9 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 Psoralite Corp. devices

FDA 510(k) Submission Details - K881385

510(k) Number K881385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date April 13, 1988
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 K881385.
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