Cleared Traditional

K093051 - HYLATOPIC PLUS EMOLLIENT FOAM

K093051 · Collegium Pharmaceutical Incorporated · General & Plastic Surgery device
Download Printable Device Report (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.

View all Collegium Pharmaceutical Incorporated devices

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 282
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