Opto Eletronica S/A
BrazilFDA applicant, unverified
- Devices
- 1
What Opto Eletronica S/A makes
Opto Eletronica S/A manufactures the OPTO HYALUS GREEN LASER, a device intended for ophthalmic procedures, specifically for corneal treatments or refractive surgeries.
The OPTO HYALUS GREEN LASER is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Opto Hyalus Green Laser Ref K111460
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Opto Eletronica S/A have in the registry?
The registry currently lists 1 device for Opto Eletronica S/A. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opto Eletronica S/A's devices?
Among its 1 most recently registered device, Opto Eletronica S/A has devices listed in FDA 510(k) (1 device).
What risk classes do Opto Eletronica S/A's devices fall under?
Among its 1 most recently registered device, the classes recorded for Opto Eletronica S/A's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Opto Eletronica S/A in the registry?
The most recently registered devices listed for Opto Eletronica S/A include OPTO HYALUS GREEN LASER.