The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan 1041 Sealed-off Co2 Surgical Laser System.
| Device ID | K900077 |
| 510k Number | K900077 |
| Device Name: | SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | S Kahan |
| Correspondent | S Kahan SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-04 |
| Decision Date | 1990-03-06 |