510(k) K233295
K233295 is an FDA 510(k) premarket notification submitted by Evolution Optiks Limited for the device "LFR-260". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code SBI (Manual Refractor, 3d Display), a Class I device regulated under 21 CFR 886.1770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2024
- Date Received
- September 29, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Refractor, 3d Display
- Device Class
- Class I
- Regulation Number
- 886.1770
- Review Panel
- OP
- Submission Type
A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.