K880427 is an FDA 510(k) clearance for the ILLUMINA 40 CO2 LASER SYSTEM. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 18, 1988, 77 days after receiving the submission on February 1, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K880427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1988 |
| Decision Date | April 18, 1988 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWG — Laser, Ent Microsurgical Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |