Leica, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Leica, Inc. makes
Leica, Inc. manufactures ophthalmic diagnostic devices, including the XCEL slit lamp for retinal and anterior segment imaging, the Unistat bilirubinometer (models 10310 and 10311) for neonatal jaundice assessment, and the Lenschek for intraocular lens measurement.
These devices are regulated under FDA Class I and Class II classifications, with some requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Xcel Slit Lamp Ref K951054
Regimes: 510(k) Registry: 510(k)Unistat Bilirubinometer Models 10310 And 10311 Ref K922770
Regimes: 510(k) Registry: 510(k)Lenschek Ref K944022
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Leica, Inc. have in the registry?
The registry currently lists 3 devices for Leica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Leica, Inc.'s devices?
Among its 3 most recently registered devices, Leica, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Leica, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Leica, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Leica, Inc. in the registry?
The most recently registered devices listed for Leica, Inc. include XCEL SLIT LAMP, UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 and LENSCHEK.