Cleared Traditional

K130350 - PROCELLERA

K130350 · Vomaris Innovations, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
140d
Days
-
Risk

K130350 is an FDA 510(k) clearance for the PROCELLERA. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Vomaris Innovations, Inc. (Chandler, US). The FDA issued a Cleared decision on July 2, 2013 after a review of 140 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 - K130350

510(k) Number K130350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2013
Decision Date July 02, 2013
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 K130350.
PROTHELIAL
K123904 · Mueller Medical International, LLC · Aug 2013
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
K131542 · Novabay Pharmaceuticals, Inc. · Jul 2013
ABSOCLEAR
K130553 · Pharmaplast S.A.E. · Jul 2013
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
K123394 · Coreleader Biotech Co., Ltd. · Jun 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
K123481 · Convatec, Inc. · Jun 2013
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
K122595 · Dermal Life, LLC · May 2013