Cleared Traditional

K122595 - HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM

K122595 · Dermal Life, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
250d
Days
-
Risk

K122595 is an FDA 510(k) clearance for the HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dermal Life, LLC (Fairfax, US). The FDA issued a Cleared decision on May 1, 2013 after a review of 250 days - an extended review 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: 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 - K122595

510(k) Number K122595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date May 01, 2013
Days to Decision 250 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
135d slower than avg
Panel avg: 115d · This submission: 250d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Journey Medical Corporation
Claude Maraoui

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K122595.
PROCELLERA
K130350 · Vomaris Innovations, Inc. · 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
MEPILEX TRANSFER AG
K123892 · Molnlycke Health Care · Apr 2013
URGOCLEAN ABSORBENT WOUND DRESSING
K123219 · Laboratoires Urgo · Mar 2013
IODOFOAM IODOPHOR FOAM DRESSING
K122634 · Progressive Wound Care Technologies, LLC · Mar 2013
K122595 · HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
Download PDF FDA Summary Dermal Life, LLC