SBI

Manual Refractor, 3d Display

Product code

SBI

Device name

Manual Refractor, 3d Display

Device class

Class 1

21 CFR

21 CFR 886.1770

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-31.

1 summaries are archived here for direct download.