The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Model 110 Nd:yag Laser.
| Device ID | K931051 |
| 510k Number | K931051 |
| Device Name: | MODEL 110 ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EXCEL TECH. LTD. 45 ADAMS AVE. Hauppauge, NY 11788 |
| Contact | Kevin G Chittim |
| Correspondent | Kevin G Chittim EXCEL TECH. LTD. 45 ADAMS AVE. Hauppauge, NY 11788 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1993-06-25 |