Mehl/Biophile Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Mehl/Biophile Intl., Inc. makes
Mehl/Biophile Intl., Inc. manufactures laser-based medical devices, including upgrades to the Mehl Ruby Laser and the ChromoScan Scanning System, which appears to be used for diagnostic imaging or analysis.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Improvements To The Mehl Ruby Laser Ref K971814
Regimes: 510(k) Registry: 510(k)Chromoscan Scanning System Ref K980753
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mehl/Biophile Intl., Inc. have in the registry?
The registry currently lists 2 devices for Mehl/Biophile Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mehl/Biophile Intl., Inc.'s devices?
Among its 2 most recently registered devices, Mehl/Biophile Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mehl/Biophile Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mehl/Biophile Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mehl/Biophile Intl., Inc. in the registry?
The most recently registered devices listed for Mehl/Biophile Intl., Inc. include IMPROVEMENTS TO THE MEHL RUBY LASER and CHROMOSCAN SCANNING SYSTEM.