The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Model 3100 Nd:yag Surgical Laser System.
| Device ID | K951165 |
| 510k Number | K951165 |
| Device Name: | SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | George J Hattub |
| Correspondent | George J Hattub 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 | 1995-03-14 |
| Decision Date | 1995-06-12 |