Cleared Traditional

K152055 - Ceramax Skin Barrier Cream

K152055 · Oculus Innovative Sciences · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
122d
Days
-
Risk

K152055 is an FDA 510(k) clearance for the Ceramax Skin Barrier Cream. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences (Petaluma, US). The FDA issued a Cleared decision on November 23, 2015 after a review of 122 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.

FDA 510(k) Submission Details - K152055

510(k) Number K152055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date November 23, 2015
Days to Decision 122 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 115d · This submission: 122d
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 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K152055.
Next Science Wound Gel
K150792 · Next Science, LLC · Dec 2015
Alevicyn SG Antipruritic Gel
K152945 · Oculus Innovative Sciences · Dec 2015
Stay Fresh Hydrocolloid dressing
K151186 · Sarasota Medical Products, Inc. · Nov 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
K150799 · Innovacyn, Inc. · Nov 2015
Medihoney Wound Gel
K150985 · Derma Sciences, Inc. · Nov 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
K152923 · Avery Dennison Belgie Bvba · Nov 2015