Cleared Traditional

K930856 - PSORALITE

K930856 is an FDA 510(k) clearance for PSORALITE, 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 189-day FDA review.

K930856 · Daavlin Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
189d
Days
Class 2
Risk

K930856 is an FDA 510(k) clearance for the PSORALITE. 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 August 26, 1993 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Daavlin Co. devices

FDA 510(k) Submission Details - K930856

510(k) Number K930856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date August 26, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 115d · This submission: 189d
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 54
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K930856.
BCLEAR
K021762 · Lumenis, Inc. · Aug 2002
HANDISOL WOUND HEALING
K982082 · National Biological Corp. · Oct 1998
UVISOL AND UVISOL II
K934808 · National Biological Corp. · Dec 1993
PHOTOTHERAPY TIMER
K924969 · National Biological Corp. · Feb 1993
HANDISOL
K924077 · National Biological Corp. · Nov 1992
PANOSOL II UVA-218
K904426 · National Biological Corp. · Dec 1990