510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860811Substantially Equivalent

Zeiss Voice Control System for Opmi's

Carl Zeiss, Inc., Thornwood NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860811 is the FDA 510(k) clearance record for ZEISS VOICE CONTROL SYSTEM FOR OPMI'S, a class I device, cleared for Carl Zeiss, Inc. on under FDA product code EPT (Microscope, Surgical). FDA records list 44 510(k) clearances for Carl Zeiss, Inc., from to . As of , FDA records show no recalls naming K860811.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EPT Microscope, Surgical
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Carl Zeiss, Inc. One Zeiss Dr., Thornwood NY
Third party review
No

Clearances, product code EPT

Trailing 12 months

FDA records hold no clearances under product code EPT in the trailing twelve months.

FDA records show no clearances under product code EPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260