Cleared Traditional

K060113 - DERMACYN WOUND CARE

K060113 · Oculus Innovative Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
36d
Days
-
Risk

K060113 is an FDA 510(k) clearance for the DERMACYN WOUND CARE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on February 22, 2006 after a review of 36 days - a notably fast clearance cycle.

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: 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 Oculus Innovative Sciences, Inc. devices

FDA 510(k) Submission Details - K060113

510(k) Number K060113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date February 22, 2006
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 607
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