K880591 is an FDA 510(k) clearance for the LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE. This device is classified as a Laser, Surgical, Gynecologic (Class II — Special Controls, product code HHR).
Submitted by Laser Peripherals, LLC (Hingham, US). The FDA issued a Cleared decision on June 1, 1988, 111 days after receiving the submission on February 11, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K880591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1988 |
| Decision Date | June 01, 1988 |
| Days to Decision | 111 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 |