K875042 is an FDA 510(k) clearance for the ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY. This device is classified as a Laser, Neurosurgical (Class III - Premarket Approval, product code LKW).
Submitted by Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on June 24, 1988, 200 days after receiving the submission on December 7, 1987.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K875042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1987 |
| Decision Date | June 24, 1988 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | LKW — Laser, Neurosurgical |
| Device Class | Class III - Premarket Approval |