K881499 is an FDA 510(k) clearance for the SURGILASE YAG 100 FOR GYNECOLOGY USE. This device is classified as a Laser, Neodymium:yag, Pulmonary Surgery (Class II - Special Controls, product code LLO).
Submitted by Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on April 29, 1988, 38 days after receiving the submission on March 22, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K881499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1988 |
| Decision Date | April 29, 1988 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | LLO — Laser, Neodymium:yag, Pulmonary Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |