LFR-260
FDA 510(k) clearance K233295 · decided 2024-05-31
Clearance details
- K-number
- K233295
- Device name
- LFR-260
- Applicant
- Evolution Optiks Limited
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-05-31
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- SBI
- Device class
- 1
- Regulation number
- 886.1770
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Christ Church, BB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.