The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan 2100 Nd:yag Laser, Series 2900 Syn. Tips.
| Device ID | K883563 |
| 510k Number | K883563 |
| Device Name: | SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Stephen Dalton |
| Correspondent | Stephen Dalton 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 | 1988-08-19 |
| Decision Date | 1988-09-27 |