The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Nd:yag Surg.laser,model 3040 Sharplaser.
| Device ID | K912792 |
| 510k Number | K912792 |
| Device Name: | SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Douglas Mead |
| Correspondent | Douglas 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 | 1991-06-25 |
| Decision Date | 1991-08-29 |