Clearance Summary
GLAUCOMA COMPANION received FDA 510(k) clearance under submission number DEN140022, sponsored by Innovatex, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2016-04-20.
- Submission: DEN140022
- Applicant / Sponsor: Innovatex, Inc.
- Clearance pathway: Direct
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5838
- Decision date: 2016-04-20
Classification & Regulation
This clearance is catalogued under FDA product code PLX and 21 CFR 886.5838, within the Ophthalmic review panel as a Class I device.