K852694 is an FDA 510(k) clearance for the PORTALASE 200 CARBON SURGICAL LASER SYSTEM. This device is classified as a Laser, Surgical, Gynecologic (Class II - Special Controls, product code HHR).
Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 30, 1985, 96 days after receiving the submission on June 26, 1985.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K852694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 26, 1985 |
| Decision Date | September 30, 1985 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4550 |