The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Co2 Lasers And Infraguide Delivery System.
| Device ID | K904423 |
| 510k Number | K904423 |
| Device Name: | CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Bob Milder |
| Correspondent | Bob Milder HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-27 |
| Decision Date | 1990-12-13 |