Zeiss Humphrey System
Country not established
- Devices
- 9
What Zeiss Humphrey System makes
The manufacturer produces ophthalmic diagnostic and surgical devices, including A/B scan ultrasound systems for retinal imaging, field analyzers for visual field testing, and image analyzers for retinal photography. Their portfolio also includes surgical lasers for ophthalmic procedures, objective refractors for measuring eye focus, and instruments for keratometry and overrefraction assessments. A digital ophthalmic biomicrocope for high-resolution imaging is also part of their offerings.
These devices are classified under Class I and Class II in the US regulatory framework, with several models authorised via the 510(k) pathway. The manufacturer’s products are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Humphrey Field Analyzer Model 630 Ref K852639
510(k) 510(k)Humphrey Image Analyzer Model 110 Ref K852638
510(k) 510(k)Zeiss Opmilas 144 Surgical Lasers Ref K942439
510(k) 510(k)Objective Refractor Ref K802029
510(k) 510(k)Autokeratometer, Instrument Ref K781994
510(k) 510(k)Digital Ophthalmic Ultrasound Biomicroscope Ref K923211
510(k) 510(k)Instruments, Overrefraction System Ref K782096
510(k) 510(k)The Humphrey Field Analyzer Model 610 Ref K821940
510(k) 510(k)
Frequently asked questions
How many devices does Zeiss Humphrey System have in the registry?
The registry currently lists 9 devices for Zeiss Humphrey System. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zeiss Humphrey System's devices?
Among its 9 most recently registered devices, Zeiss Humphrey System has devices listed in FDA 510(k) (9 devices).
What risk classes do Zeiss Humphrey System's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Zeiss Humphrey System's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zeiss Humphrey System in the registry?
The most recently registered devices listed for Zeiss Humphrey System include OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED, HUMPHREY FIELD ANALYZER MODEL 630, HUMPHREY IMAGE ANALYZER MODEL 110 and ZEISS OPMILAS 144 SURGICAL LASERS.