The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vari-lase Platinum Bright Tip Laser Fiber.
| Device ID | K091551 |
| 510k Number | K091551 |
| Device Name: | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Loucinda Bjorklund |
| Correspondent | Loucinda Bjorklund VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2009-06-19 |
| Summary: | summary |