Optical Radiation Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Optical Radiation Corp. makes
Optical Radiation Corp. manufactures optical radiation measurement devices, including the ORACLE system for dosimetry and radiometry, as well as specialized optical filters like COMPUTON® and high-index lenses (OR-160, ORCOLITE 1.60). The company also produces contact lens materials, such as ORCOLON® (polyacrylamide), used in ophthalmic applications.
The portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with some products authorised via 510(k) clearances and others through PMA submissions. These devices are listed in the FDA registry, and the company is based in the United States.
Catalogue
Orc Oracle Ref K853668
Regimes: 510(k) Registry: 510(k)Computon(R) Ref K863200
Regimes: 510(k) Registry: 510(k)0R 160, Or-1.60, And Orcolite 1.60 High Index Ref K920795
Regimes: 510(k) Registry: 510(k)Orcolon (R) (Polyacrylamide) Ref P900010
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Optical Radiation Corp. have in the registry?
The registry currently lists 4 devices for Optical Radiation Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optical Radiation Corp.'s devices?
Among its 4 most recently registered devices, Optical Radiation Corp. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Optical Radiation Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Optical Radiation Corp.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Optical Radiation Corp. in the registry?
The most recently registered devices listed for Optical Radiation Corp. include ORC ORACLE, COMPUTON(R), 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX and ORCOLON (R) (POLYACRYLAMIDE).