Cleared Traditional

K093051 - HYLATOPIC PLUS EMOLLIENT FOAM

K093051 · Collegium Pharmaceutical Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
68d
Days
-
Risk

K093051 is an FDA 510(k) clearance for the HYLATOPIC PLUS EMOLLIENT FOAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Collegium Pharmaceutical Incorporated (Cumberland, US). The FDA issued a Cleared decision on December 7, 2009 after a review of 68 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.

FDA 510(k) Submission Details - K093051

510(k) Number K093051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date December 07, 2009
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
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 686
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K093051.
MEDLINE CURAD WOUND DRESSINGS
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SILVERSTREAM AND DERMASEPT
K093227 · Enzysurge , Ltd. · Dec 2009
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · American Biotech Labs · Nov 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
K083133 · Andover Healthcare, Inc. · Oct 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
K091354 · Acrymed, Inc. · Oct 2009
K093051 · HYLATOPIC PLUS EMOLLIENT FOAM
Download PDF FDA Summary Collegium Pharmaceuti…