510(k) K231760
K231760 is an FDA 510(k) premarket notification submitted by Cylite Pty. , Ltd. for the device "HP-OCT (HP-OCT)". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Cylite Pty. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2024
- Date Received
- June 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type