Squalus Med, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Squalus Med, Ltd. makes
Squalus Med, Ltd. manufactures the MANTA Laser, a medical device designed for laser-based tissue treatment or ablation procedures.
The MANTA Laser is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
MANTA Laser Ref K222701
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Squalus Med, Ltd. have in the registry?
The registry currently lists 1 device for Squalus Med, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Squalus Med, Ltd.'s devices?
Among its 1 most recently registered device, Squalus Med, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Squalus Med, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Squalus Med, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Squalus Med, Ltd. in the registry?
The most recently registered devices listed for Squalus Med, Ltd. include MANTA Laser.