K233295 is an FDA 510(k) clearance for the LFR-260. This device is classified as a Manual Refractor, 3d Display (Class I - General Controls, product code SBI).
Submitted by Evolution Optiks Limited (Christ Church, BB). The FDA issued a Cleared decision on May 31, 2024, 245 days after receiving the submission on September 29, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1770. A 3d Display Manual Refractor Is An Optical Device Intended To Measure The Refractive Error Of The Eye..
| 510(k) Number | K233295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | May 31, 2024 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | SBI - Manual Refractor, 3d Display |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1770 |
| Definition | A 3d Display Manual Refractor Is An Optical Device Intended To Measure The Refractive Error Of The Eye. |