510(k) DEN230043
DEN230043 is an FDA 510(k) premarket notification submitted by Notal Vision, Inc. for the device "Notal Vision Home Optical Coherence Tomography (OCT) System". The FDA issued a decision of De Novo Granted on May 15, 2024. The device falls under product code SAX (Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device), a Class II device regulated under 21 CFR 886.1600. Notal Vision, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 15, 2024
- Date Received
- June 7, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Device Class
- Class II
- Regulation Number
- 886.1600
- Review Panel
- OP
- Submission Type
A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.