Cleared Traditional

K061589 - SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY

K061589 is an FDA 510(k) clearance for SOLARC / SOLRX HANDHELD ULTRAVIOLET PHO..., manufactured by Solarc Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K061589 · Solarc Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
57d
Days
Class 2
Risk

K061589 is an FDA 510(k) clearance for the SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Solarc Systems, Inc. (Barrie, Ontario, CA). The FDA issued a Cleared decision on August 4, 2006 after a review of 57 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.

FDA 510(k) Submission Details - K061589

510(k) Number K061589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date August 04, 2006
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 155
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K061589.
RESOLVE UVB PHOTOTHERAPY SYSTEM
K072035 · Allux Medical · Oct 2007
PANOSOL II TRU-BLU, MODEL UBL-417
K070934 · National Biological Corp. · May 2007
3 SERIES PHOTOTHERAPY CABINET
K063621 · Daavlin Co. · Jan 2007
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
K061295 · Theralight, Inc. · May 2006
UVBIOTEK MODELS 3200B AND 4000B
K051330 · Medtek Lighting Corporation · Nov 2005
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT)
K052660 · The Richmond Light Co. · Oct 2005
K061589 · SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Download PDF FDA Summary Solarc Systems, Inc.