The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplase Short Fiber Nd:yag Delivery System.
| Device ID | K931978 |
| 510k Number | K931978 |
| Device Name: | SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM |
| 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 | 1993-04-22 |
| Decision Date | 1993-09-23 |