The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Illumina 25 Co2 Laser System.
| Device ID | K880428 |
| 510k Number | K880428 |
| Device Name: | ILLUMINA 25 CO2 LASER SYSTEM |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-01 |
| Decision Date | 1988-04-18 |