SBI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Manual Refractor, 3d Display
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1770
- Medical specialty
- Ophthalmic
- FDA definition
- A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LFR-260 (K233295) | Evolution Optiks Limited | 2024-05-31 |
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