Cleared Traditional

K072035 - RESOLVE UVB PHOTOTHERAPY SYSTEM

K072035 is an FDA 510(k) clearance for RESOLVE UVB PHOTOTHERAPY SYSTEM, manufactured by Allux Medical. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K072035 · Allux Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
83d
Days
Class 2
Risk

K072035 is an FDA 510(k) clearance for the RESOLVE UVB PHOTOTHERAPY SYSTEM. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Allux Medical (Menlo Park, US). The FDA issued a Cleared decision on October 16, 2007 after a review of 83 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 - K072035

510(k) Number K072035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2007
Decision Date October 16, 2007
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 183
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K072035.
VERSA LITE
K073503 · Diomedics, Inc. · Jan 2008
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K073587 · Daavlin Distributing Co. · Jan 2008
308 DERMATOLOGICAL EXCIMER SYSTEM
K073066 · Quantel Medical, Inc. · Dec 2007
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K070934 · National Biological Corp. · May 2007
3 SERIES PHOTOTHERAPY CABINET
K063621 · Daavlin Co. · Jan 2007
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K061589 · Solarc Systems, Inc. · Aug 2006
K072035 · RESOLVE UVB PHOTOTHERAPY SYSTEM
Download PDF FDA Summary Allux Medical