The following data is part of a premarket notification filed by Xintec Corporation, Dba, with the FDA for Vectra Laser System.
| Device ID | K060114 |
| 510k Number | K060114 |
| Device Name: | VECTRA LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION, DBA, 1660 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | Marilyn M Chou |
| Correspondent | Marilyn M Chou XINTEC CORPORATION, DBA, 1660 SOUTH LOOP ROAD Alameda, CA 94502 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-04-07 |
| Summary: | summary |