Balance Ophthalmics, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3027866078
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System Ref DEN230055
Regimes: De Novo Registry: De NovoFSYX Ocular Pressure Adjusting Pump Ref K252455
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3027866078
- Address
- 3101 W 57th Street, Sioux Falls, SD, 57108
Frequently asked questions
How many devices does Balance Ophthalmics, Inc. have in the registry?
The registry currently lists 6 devices for Balance Ophthalmics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Balance Ophthalmics, Inc.'s devices?
Among its 6 most recently registered devices, Balance Ophthalmics, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Balance Ophthalmics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Balance Ophthalmics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Balance Ophthalmics, Inc. in the registry?
The most recently registered devices listed for Balance Ophthalmics, Inc. include FSYX Goggles - Small 400-6009-001, FSYX Goggles - Large 400-6009-003, FSYX Goggles - Medium 400-6009-002 and FSYX Ocular Pressure Adjusting Pump 400-6008-00.