The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel's Est-30 Ho:yag Laser System.
| Device ID | K932730 |
| 510k Number | K932730 |
| Device Name: | EXCEL'S EST-30 HO:YAG LASER SYSTEM |
| 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 | 1993-06-07 |
| Decision Date | 1994-03-01 |