Zeiss Voice Control System for Opmi's

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860811 ↗

FDA Product Code

EPT

Device Class

Class I

Regulation

21 CFR Part 878.4700

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Carl Zeiss, Inc. →