Clearance Summary
Notal Vision Home Optical Coherence Tomography (OCT) System received FDA 510(k) clearance under submission number DEN230043, sponsored by Notal Vision, 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 2024-05-15.
- Submission: DEN230043
- Applicant / Sponsor: Notal Vision, Inc.
- Clearance pathway: Direct
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1600
- Decision date: 2024-05-15
Classification & Regulation
This clearance is catalogued under FDA product code SAX and 21 CFR 886.1600, within the Ophthalmic review panel as a Class II device.