Cleared Traditional

K090206 - OCULUS PURACYN ANTIMICROBIAL SKIN AND W...

K090206 · Oculus Innovative Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
125d
Days
-
Risk

K090206 is an FDA 510(k) clearance for the OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Oculus Innovative Sciences, Inc. devices

FDA 510(k) Submission Details - K090206

510(k) Number K090206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2009
Decision Date June 02, 2009
Days to Decision 125 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K090206.
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S · Feb 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc. · Jan 2010
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc. · Jul 2009
PROWICK
K083007 · Arthrex, Inc. · Apr 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc. · Mar 2009
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · B.Braun Medical, Inc. · Jun 2008