Cleared Traditional

K001508 - LASERSKIN DRESSING

K001508 · Fidia Advanced Biopolymers Srl · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
436d
Days
-
Risk

K001508 is an FDA 510(k) clearance for the LASERSKIN DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Fidia Advanced Biopolymers Srl (Abano Terme, IT). The FDA issued a Cleared decision on July 25, 2001 after a review of 436 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Fidia Advanced Biopolymers Srl devices

FDA 510(k) Submission Details - K001508

510(k) Number K001508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2000
Decision Date July 25, 2001
Days to Decision 436 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
321d slower than avg
Panel avg: 115d · This submission: 436d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 13
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K001508.
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc. · Jul 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995