The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Thermoxel Co2 Laser System And Delivery Device Accessories.
| Device ID | K080463 |
| 510k Number | K080463 |
| Device Name: | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-07-23 |
| Summary: | summary |