Product areas
FDA product code distribution
Gyrus Acmi, Inc.
Country / region:United States (US)
510(k) submissions
2
Filtered: GEX
Latest clearance
2023-01-27
Product codes
1
GEX
510(k) submissions
2 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | GEX | Class 2 | 2023-01-27 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | Class 2 | 2021-06-03 |
Company profile
- Canonical name
- Gyrus Acmi, Inc.
- Country
- United States(US)
Cited predicates
3- K183647
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
- K211401
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K183647
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Gyrus Acmi, Inc. references 3 predicate/reference devices
Cited as predicate
3- K242191
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K232568
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- K221306
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
3 submissions cite Gyrus Acmi, Inc. as a predicate