510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181444Substantially Equivalent

Clarus

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

K181444 is the FDA 510(k) clearance record for CLARUS, a class II device, cleared for Carl Zeiss Meditec, Inc. on under FDA product code QER (Camera, Ophthalmic, Slit-Scanning). FDA's definition for product code QER reads: "An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area". FDA records list 78 510(k) clearances for Carl Zeiss Meditec, Inc., from to . As of , FDA records show no recalls naming K181444.

Clearance record

Decision date
Received
(223 days to decision)
Product code
QER Camera, Ophthalmic, Slit-Scanning
Regulation
21 CFR 886.1120
Device class
Class II
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 QER

Trailing 12 months

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

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