Optopics Laboratories Corp.
Country not established
- Devices
- 3
What Optopics Laboratories Corp. makes
Optopics Laboratories Corp. manufactures solutions for maintaining and preserving hard contact lenses, including wetting solutions, disinfecting sprays, and saline-based preservative solutions with pH adjustment.
These products are regulated as Class II medical devices in the US, with some models authorised via FDA 510(k) and others through FDA PMA pathways. The company’s devices are listed under these regulatory mechanisms.
Catalogue
Wetting Solution For Hard Contact Lenses Ref K914483
Regimes: 510(k) Registry: 510(k)Steridyne Dynaspray Ref P860050
Regimes: PMA Registry: PMASorbic Acid Preserved Saline Sol.ph Change Ref P870007
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Optopics Laboratories Corp. have in the registry?
The registry currently lists 3 devices for Optopics Laboratories Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optopics Laboratories Corp.'s devices?
Among its 3 most recently registered devices, Optopics Laboratories Corp. has devices listed in FDA 510(k) (1 device) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Optopics Laboratories Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Optopics Laboratories Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optopics Laboratories Corp. in the registry?
The most recently registered devices listed for Optopics Laboratories Corp. include WETTING SOLUTION FOR HARD CONTACT LENSES, STERIDYNE DYNASPRAY and SORBIC ACID PRESERVED SALINE SOL.PH CHANGE.