K001508 is an FDA 510(k) clearance for the LASERSKIN DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Fidia Advanced Biopolymers Srl (Abano Terme, IT). The FDA issued a Cleared decision on July 25, 2001, 436 days after receiving the submission on May 15, 2000.
This device falls under the General & Plastic Surgery FDA review panel.
| 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 |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |