Cleared Traditional

LASERSKIN DRESSING (K001508) - FDA 510(k) Clearance

K001508 · Fidia Advanced Biopolymers Srl · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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