Netoptix Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Netoptix Corp. makes
Netoptix Corp. manufactures the Leisegang Video Colposcope, a device used for examining the cervix and vaginal tissues with video imaging, and the Galileo disposable hysteroscopes, which allow internal uterine inspections. The company also produces the Galileo High Resolution Micro Coupler, a component for enhancing imaging resolution in hysteroscopic procedures.
The company’s hysteroscopes and colposcope are classified as Class II medical devices under FDA regulations, with each product authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. Netoptix Corp. is based in the United States.
Catalogue
Leisegang Video Colposcope Ref K981958
Regimes: 510(k) Registry: 510(k)Galileo Disposable Hysteroscopes Ref K981828
Regimes: 510(k) Registry: 510(k)Galileo High Resolution Micro Coupler Ref K971896
Regimes: 510(k) Registry: 510(k)Galileo Disposable Hysteroscopes Ref K974297
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Netoptix Corp. have in the registry?
The registry currently lists 4 devices for Netoptix Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Netoptix Corp.'s devices?
Among its 4 most recently registered devices, Netoptix Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Netoptix Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Netoptix Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Netoptix Corp. in the registry?
The most recently registered devices listed for Netoptix Corp. include LEISEGANG VIDEO COLPOSCOPE, GALILEO DISPOSABLE HYSTEROSCOPES and GALILEO HIGH RESOLUTION MICRO COUPLER.