The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Co2 Lasers, Model Numbers 1050 And 1075.
| Device ID | K903230 |
| 510k Number | K903230 |
| Device Name: | SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Mark Plotts |
| Correspondent | Mark Plotts SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-23 |
| Decision Date | 1990-10-11 |