510(k) K232555
K232555 is an FDA 510(k) premarket notification submitted by Topcon Healthcare Solutions for the device "Harmony". The FDA issued a decision of Substantially Equivalent on November 20, 2023. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Topcon Healthcare Solutions has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2023
- Date Received
- August 23, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type