The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Co2 Surg. Laser, Mo. 1039 Surgicenter 40.
| Device ID | K921146 |
| 510k Number | K921146 |
| Device Name: | SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Douglass Mead |
| Correspondent | Douglass Mead 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 | 1992-03-10 |
| Decision Date | 1992-06-08 |