The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Co2 Laser Systems & Arthroguide Co2 Laser Fiber.
| Device ID | K893832 |
| 510k Number | K893832 |
| Device Name: | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Donna Page |
| Correspondent | Donna Page 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 | 1989-05-24 |
| Decision Date | 1989-08-09 |