Bio-Tissue, Inc.
Country not established
- Devices
- 1
What Bio-Tissue, Inc. makes
Bio-Tissue, Inc. manufactures AMNIOLENS, a tissue-based ophthalmic device used for corneal repair and regeneration.
The AMNIOLENS is classified as a Class II medical device and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Amniolens Ref K032104
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Tissue, Inc. have in the registry?
The registry currently lists 1 device for Bio-Tissue, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Tissue, Inc.'s devices?
Among its 1 most recently registered device, Bio-Tissue, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Bio-Tissue, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bio-Tissue, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Tissue, Inc. in the registry?
The most recently registered devices listed for Bio-Tissue, Inc. include AMNIOLENS.