Product areas
FDA product code distribution
Gyrus Acmi, Inc.
Country / Region:United States (US)Website:gyrus.com
510(k) submissions
3
Filtered: GEX
Latest clearance
2026-03-02
Product codes
2
GEX, GEI
510(k) submissions
2 total · filtered by GEX
Showing 1–2
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| 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 / Region
- United States(US)
- Address
- 800 W. Park Dr. Westborough, MA 01581
- Website
- gyrus.com
Predicate manufacturers
Companies whose devices this company cited as predicates
2 manufacturers
- 2
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
3 manufacturers
- 1
- 1
- 1