The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Vectra Plus Laser System And Accessories.
| Device ID | K082230 |
| 510k Number | K082230 |
| Device Name: | VECTRA PLUS LASER SYSTEM AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION 1660 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Marilyn M Chou |
| Correspondent | Marilyn M Chou XINTEC CORPORATION 1660 SOUTH LOOP RD. 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 | 2008-08-07 |
| Decision Date | 2010-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855430006487 | K082230 | 000 |
| 00855430006050 | K082230 | 000 |
| 00855430006067 | K082230 | 000 |
| 00855430006074 | K082230 | 000 |
| 00855430006081 | K082230 | 000 |
| 00855430006098 | K082230 | 000 |
| 00855430006104 | K082230 | 000 |
| 00855430006401 | K082230 | 000 |
| 00855430006418 | K082230 | 000 |
| 00855430006456 | K082230 | 000 |
| 00855430006463 | K082230 | 000 |
| 00855430006470 | K082230 | 000 |
| 00855430006043 | K082230 | 000 |