The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Soltive Laser System (soltive Pro Superpulsed Laser, Soltive Premium Superpulsed Laser, Soltive Laser Fibers, And Accessories).
| Device ID | K211401 |
| 510k Number | K211401 |
| Device Name: | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 |
| Contact | Julie Acker |
| Correspondent | Julie Acker Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-06-03 |