FDA product code SBI: Manual Refractor, 3d Display
SBI is the FDA product code for manual refractor, 3d display. It is a Class I device, regulated under 21 CFR 886.1770 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under SBI, 1 in the last five years. The average 510(k) review took 245 days (median 245); 245 days on average over the last three years.
Definition
A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
Classification
| Field | Value |
|---|---|
| Device name | Manual Refractor, 3d Display |
| Device class | Class I |
| Regulation | 21 CFR 886.1770 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 245 |
Compare with all 510(k) review times · Search every SBI clearance
Top SBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Evolution Optiks Limited | 1 | 2024-05-31 |
Most recent SBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233295 | Evolution Optiks Limited | LFR-260 | 2024-05-31 | 245 |
Recalls for SBI devices
openFDA lists no recalls for product code SBI.
Frequently asked questions
What is FDA product code SBI?
SBI is the FDA product code for manual refractor, 3d display. It is a Class I device, regulated under 21 CFR 886.1770 and reviewed by the Ophthalmic panel.
What device class is SBI?
Class I, regulation 21 CFR 886.1770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SBI?
Across 1 cleared submissions the average was 245 days from receipt to decision (median 245).
Which companies have the most SBI clearances?
Evolution Optiks Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBI
- Run a recall and safety report across every SBI manufacturer
- Watch product code SBI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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