The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Sharplase Family Nd:yag Sculpted Fibers.
| Device ID | K913037 |
| 510k Number | K913037 |
| Device Name: | SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Dougalss Mead |
| Correspondent | Dougalss 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 | 1991-07-09 |
| Decision Date | 1991-09-06 |