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 58
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K001508.
FASTSEAL CHEST WOUND DRESSING
K990079 · Greenfield Medical Technologies, Inc. · Dec 1999
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · Dermaphylyx, Inc. · Sep 1999
GILTECH PLUS TRANSPARENT DRESSING
K992005 · Giltech Plus, Inc. · Sep 1999
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
K990875 · Dermaphylyx, Inc. · May 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
K990438 · Dermaphylyx, Inc. · Mar 1999