The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Ultrawave Ii Ex 1320.
| Device ID | K070805 |
| 510k Number | K070805 |
| Device Name: | ULTRAWAVE II EX 1320 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTA SYSTEM, S.P.A. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan QUANTA SYSTEM, S.P.A. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-23 |
| Decision Date | 2007-07-11 |
| Summary: | summary |