The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Duopulse Model 3000 Combination Ho/er:yag.
| Device ID | K922375 |
| 510k Number | K922375 |
| Device Name: | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EXCEL TECH. LTD. 101-2 COLIN DR. Holbrook, NY 11741 |
| Contact | Rama Rao |
| Correspondent | Rama Rao EXCEL TECH. LTD. 101-2 COLIN DR. Holbrook, NY 11741 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-07-08 |