Entravision, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Entravision, Inc. makes
Entravision, Inc. manufactures vitrectomy handpieces and intraocular aspiration (I/A) systems for ophthalmic surgery, including the MODECO II vitrectomy handpiece and the EP-500 I/A ECCO pack. These devices are designed for vitreous cutting and fluid management during retinal procedures. The company also produces a combined I/A machine and handpiece system for automated intraocular irrigation and aspiration.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database. Entravision, Inc. is based in the United States.
Catalogue
Entravision Modeco Ii Vitreous Cutting Handpiece Ref K870775
Regimes: 510(k) Registry: 510(k)Entravision Ep-500 I/A Ecco Pack Ref K862064
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entravision, Inc. have in the registry?
The registry currently lists 3 devices for Entravision, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entravision, Inc.'s devices?
Among its 3 most recently registered devices, Entravision, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Entravision, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Entravision, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entravision, Inc. in the registry?
The most recently registered devices listed for Entravision, Inc. include ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE, ENTRAVISION EP-500 I/A ECCO PACK and ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE.