Product code SAX— Ophthalmic
Notal Vision Home Optical Coherence Tomography (OCT) System
- Classification name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Device class
- Class 2
- Regulation
- 21 CFR 886.1600
- Advisory panel
- Ophthalmic
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code SAX
FDA has cleared device under product code SAX, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SAX
Recent clearances under product code SAX
Data sourced from openFDA. This site is unofficial and independent of the FDA.