The following data is part of a premarket notification filed by Satelec with the FDA for Lasersat Co2.
| Device ID | K904067 |
| 510k Number | K904067 |
| Device Name: | LASERSAT CO2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex, FR 33708 |
| Contact | Dupeyron |
| Correspondent | Dupeyron SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex, FR 33708 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-31 |
| Decision Date | 1990-11-07 |