510(k) K231222
K231222 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)". The FDA issued a decision of Substantially Equivalent on October 30, 2023. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Topcon Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2023
- Date Received
- April 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tomography, Optical Coherence
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.