Cleared Traditional

K103540 - PSORIA-LIGHT

K103540 is an FDA 510(k) clearance for PSORIA-LIGHT, manufactured by Psoria-Shield, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K103540 · Psoria-Shield, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
70d
Days
Class 2
Risk

K103540 is an FDA 510(k) clearance for the PSORIA-LIGHT. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Psoria-Shield, Inc. (Odessa, US). The FDA issued a Cleared decision on February 10, 2011 after a review of 70 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 Psoria-Shield, Inc. devices

FDA 510(k) Submission Details - K103540

510(k) Number K103540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2010
Decision Date February 10, 2011
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
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 88
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K103540.
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
K111172 · Daavlin Distributing Co. · Aug 2011
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K103204 · Solarc Systems, Inc. · Apr 2011
ML24000 UVA-1 PHOTOTHERAPY UNIT
K103708 · The Daavlin Distributing Company · Feb 2011
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
K100378 · Daavlin Distributing Co. · Apr 2010
LH-75 PHOTOTHERAPY SYSTEM
K091568 · Lerner Medical Devices, Inc. · Nov 2009
LH-75T PHOTOTHERAPY SYSTEM
K090097 · Lerner Medical Devices, Inc. · Feb 2009