The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Carbon Dioxide Laser Systems W/waveguide Delivery.
| Device ID | K910530 |
| 510k Number | K910530 |
| Device Name: | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath 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 | 1991-02-08 |
| Decision Date | 1991-10-31 |