510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093213Substantially Equivalent

Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series

Carl Zeiss Meditec Inc, Dublin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093213 is the FDA 510(k) clearance record for GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES, a class I device, cleared for Carl Zeiss Meditec, Inc. on under FDA product code HPT (Perimeter, Automatic, Ac-Powered). FDA records list 78 510(k) clearances for Carl Zeiss Meditec, Inc., from to . As of , FDA records show no recalls naming K093213.

Clearance record

Decision date
Received
(150 days to decision)
Product code
HPT Perimeter, Automatic, Ac-Powered
Regulation
21 CFR 886.1605
Device class
Class I
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, Inc. 5160 Hacienda Dr., Dublin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HPT

Trailing 12 months

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

FDA records show no clearances under product code HPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPT, 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