Optoline S.r.l.
ItalyFDA applicant, unverified
- Devices
- 1
What Optoline S.r.l. makes
Optoline S.R.L. manufactures Class I medical devices, including optical and diagnostic tools designed for clinical or procedural use, though specific device names are not provided in the records.
The company’s portfolio is regulated under the FDA’s 510(k) pathway for Class I devices and is listed in the U.S. regulatory database. The company is based in the United States.
Catalogue
Opto Line SRL Ref K933809
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optoline S.R.L. have in the registry?
The registry currently lists 1 device for Optoline S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optoline S.R.L.'s devices?
Among its 1 most recently registered device, Optoline S.R.L. has devices listed in FDA 510(k) (1 device).
What risk classes do Optoline S.R.L.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Optoline S.R.L.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Optoline S.R.L. in the registry?
The most recently registered devices listed for Optoline S.R.L. include OPTO LINE SRL.