SBI — Manual Refractor, 3d Display Class I
FDA product code SBI covers "Manual Refractor, 3d Display", a Class I medical device regulated under 21 CFR 886.1770. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBI
- Device Class
- Class I
- Regulation Number
- 886.1770
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233295 | evolution optiks limited | LFR-260 | May 31, 2024 |