Product areas
FDA product code distribution
Olympus Surgical Technologies America
Country / region:United States (US)
510(k) submissions
2
Filtered: GEX
Latest clearance
2024-08-23
Product codes
1
GEX
510(k) submissions
2 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | Class 2 | 2024-08-23 |
| K183647 | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) | GEX | Class 2 | 2019-08-09 |
Company profile
- Canonical name
- Olympus Surgical Technologies America
- Country
- United States(US)
Cited predicates
3- K221306
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K103654
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Not ingested - K170121
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Olympus Surgical Technologies America references 3 predicate/reference devices
Cited as predicate
9- K252971
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251824
Patriot Duo
- K251303
Tamburo Thulium Fiber Laser System
- K250504
Leonardo Duster
- K242987
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- K242293
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
- K221306
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K211517
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
- K211401
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
9 submissions cite Olympus Surgical Technologies America as a predicate