Zeiss Humphrey System

Walker, MI, US

Zeiss Humphrey System appears in FDA device records in Walker, MI. FDA records list 9 510(k) clearances between 1979-01-26 and 1994-07-01, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 9
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 9 510(k) clearances for Zeiss Humphrey System between 1979 and 1994. The busiest year on record is 1979, with 2. The most recent is 1994, with 1.

Clearances by year, as a table

510(k) clearance decisions for Zeiss Humphrey System, by decision year
Year	Clearances
1979	2
1980	1
1982	1
1985	2
1992	1
1993	1
1994	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K942439	ZEISS OPMILAS 144 SURGICAL LASERS	GEX	Substantially Equivalent	1994-07-01
K923211	DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE	IYO	Substantially Equivalent	1993-11-08
K923348	OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED	ITX	Substantially Equivalent	1992-12-10
K852639	HUMPHREY FIELD ANALYZER MODEL 630	HPT	Substantially Equivalent	1985-09-18
K852638	HUMPHREY IMAGE ANALYZER MODEL 110	HKI	Substantially Equivalent	1985-08-12
K821940	THE HUMPHREY FIELD ANALYZER MODEL 610	HPT	Substantially Equivalent	1982-07-28
K802029	OBJECTIVE REFRACTOR	HKO	Substantially Equivalent	1980-11-12
K781994	AUTOKERATOMETER, INSTRUMENT	HLQ	Substantially Equivalent	1979-02-12
K782096	INSTRUMENTS, OVERREFRACTION SYSTEM	HLM	Substantially Equivalent	1979-01-26

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain