K880930 is an FDA 510(k) clearance for the MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE. This device is classified as a Laser, Surgical, Gynecologic (Class II — Special Controls, product code HHR).
Submitted by Copper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 31, 1988, 88 days after receiving the submission on March 4, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K880930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1988 |
| Decision Date | May 31, 1988 |
| Days to Decision | 88 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 |