Cleared Traditional

K102945 - PEDIACYN ATOPIC DERMATITIS HYDROGEL

K102945 · Oculus Innovative Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
121d
Days
-
Risk

K102945 is an FDA 510(k) clearance for the PEDIACYN ATOPIC DERMATITIS HYDROGEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 121 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 - K102945

510(k) Number K102945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date February 02, 2011
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
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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