Intl. Ophthalmic Industries Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Intl. Ophthalmic Industries Corp. makes
Intl. Ophthalmic Industries Corp. manufactures surgical equipment for ophthalmic procedures, including phacoemulsification units for cataract lens removal, electronic control units for laser systems, and diathermy units for tissue coagulation. Their portfolio also includes trephines for corneal surgery and integrated ophthalmic surgical systems like the Megatron, designed for precision eye procedures.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) clearance registry. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Phacoemulsification Unit To Remove Catarac. Lens Ref K894512
Regimes: 510(k) Registry: 510(k)Magnetron Munich Model Electronic Control Unit Ref K894511
Regimes: 510(k) Registry: 510(k)Aspitron Ref K823088
Regimes: 510(k) Registry: 510(k)Diathron(R) Diathermy Unit Ref K894513
Regimes: 510(k) Registry: 510(k)(Micro-Keratron, Micro Duct Trephine) Ref K791763
Regimes: 510(k) Registry: 510(k)Megatron Ophthalmic Surgical System Ref K961658
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intl. Ophthalmic Industries Corp. have in the registry?
The registry currently lists 6 devices for Intl. Ophthalmic Industries Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Ophthalmic Industries Corp.'s devices?
Among its 6 most recently registered devices, Intl. Ophthalmic Industries Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Intl. Ophthalmic Industries Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Intl. Ophthalmic Industries Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intl. Ophthalmic Industries Corp. in the registry?
The most recently registered devices listed for Intl. Ophthalmic Industries Corp. include PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS, MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT, ASPITRON and DIATHRON(R) DIATHERMY UNIT.