510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K052268Substantially Equivalent

Visucam Pro Nm

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

K052268 is the FDA 510(k) clearance record for VISUCAM PRO NM, a class II device, cleared for Carl Zeiss Meditec, AG on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list 78 510(k) clearances for Carl Zeiss Meditec, AG, from to . As of , FDA records show no recalls naming K052268.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, AG 5160 Hacienda Dr., Dublin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260