The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vari-lase Bright Tip Fiber.
| Device ID | K070216 |
| 510k Number | K070216 |
| Device Name: | VARI-LASE BRIGHT TIP FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Deborah L Neymark |
| Correspondent | Deborah L Neymark VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-23 |
| Decision Date | 2007-03-16 |
| Summary: | summary |