510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021787Substantially Equivalent

Visucam

Carl Zeiss Meditec Inc, Washington DC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021787 is the FDA 510(k) clearance record for VISUCAM, a class I device, cleared for Carl Zeiss Ophthalmic Systems, Inc. on under FDA product code NFF (Device, Storage, Images, Ophthalmic). FDA records list 78 510(k) clearances for CARL ZEISS MEDITEC INC, from to . As of , FDA records show no recalls naming K021787.

Clearance record

Decision date
Received
(22 days to decision)
Product code
NFF Device, Storage, Images, Ophthalmic
Regulation
21 CFR 892.2010
Device class
Class I
Review panel
Radiology
Applicant
Carl Zeiss Ophthalmic Systems, Inc. 555 Thireenth St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFF

Trailing 12 months

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

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