K864166 is an FDA 510(k) clearance for the 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY. This device is classified as a Laser, Neurosurgical (Class III - Premarket Approval, product code LKW).
Submitted by Weck Surgical Systems (Hauppauge, US). The FDA issued a Cleared decision on February 10, 1987, 110 days after receiving the submission on October 23, 1986.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K864166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1986 |
| Decision Date | February 10, 1987 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | LKW — Laser, Neurosurgical |
| Device Class | Class III - Premarket Approval |