Lensx Lasers, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Lensx Lasers, Inc. makes
Lensx Lasers, Inc. manufactures femtosecond laser systems designed for cataract surgery, including the LENSX 550 Laser System and its variants. These devices perform laser-assisted capsulotomy and lens fragmentation to enable precise cataract removal and intraocular lens implantation.
The company’s laser systems are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Lensx 550 Laser System. Model 550 Ref K094052
Regimes: 510(k) Registry: 510(k)Lensx 550 Laser System Ref K092647
Regimes: 510(k) Registry: 510(k)Lensx Laser System Ref K101626
Regimes: 510(k) Registry: 510(k)Lensx 550 Laser System Ref K082947
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lensx Lasers, Inc. have in the registry?
The registry currently lists 4 devices for Lensx Lasers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lensx Lasers, Inc.'s devices?
Among its 4 most recently registered devices, Lensx Lasers, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Lensx Lasers, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Lensx Lasers, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lensx Lasers, Inc. in the registry?
The most recently registered devices listed for Lensx Lasers, Inc. include LENSX 550 LASER SYSTEM. MODEL 550, LENSX 550 LASER SYSTEM and LENSX LASER SYSTEM.