The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Sharplan 1040 Co/2 Surgical Laser.
| Device ID | K850628 |
| 510k Number | K850628 |
| Device Name: | SHARPLAN 1040 CO/2 SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER INDUSTRIES LTD. PENNIE & EDMONDS 1155 AVENUE OF THE AMERICAS New York, NY 10036 |
| Contact | Frank E Morris |
| Correspondent | Frank E Morris LASER INDUSTRIES LTD. PENNIE & EDMONDS 1155 AVENUE OF THE AMERICAS New York, NY 10036 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-08-07 |