510(k) K233295
- Device
- LFR-260
- Applicant
- Evolution Optiks Limited
- 510(k) number
- K233295
- Product code
- SBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-31
- Date received
- 2023-09-29
- Regulation
- 886.1770
- Classification name
- Manual Refractor, 3d Display
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Raul Mihali
- Address
- Pasea Financial Centre Corner Harts Gap & Dayrells Rd. Christ Church BB BB14030 BB14030