510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180895Substantially Equivalent

Alleye

Oculocare Medical AG, Zurich, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180895 is the FDA 510(k) clearance record for Alleye, a class I device, cleared for Oculocare Medical AG on under FDA product code HOQ (Grid, Amsler). FDA records list one 510(k) clearance for Oculocare Medical AG. As of , FDA records show no recalls naming K180895.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HOQ Grid, Amsler
Regulation
21 CFR 886.1330
Device class
Class I
Review panel
Ophthalmic
Applicant
Oculocare Medical AG Verena Conzett Strasse 9, Zurich, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HOQ

Trailing 12 months

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

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