The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Illumina Model 40 Co2 Laser For General/plastic Su.
| Device ID | K880808 |
| 510k Number | K880808 |
| Device Name: | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-04-18 |