Alleye— 510(k) K180895

Substantially Equivalent

Oculocare Medical AG

FDA 510(k) clearance K180895 for Alleye, Substantially Equivalent on 2018-06-27. Applicant: Oculocare Medical AG. Device class: 1.

Clearance details

Applicant: Oculocare Medical AG
Product code: Code HOQ
Device class: Class 1
Regulation: 21 CFR 886.1330
Advisory panel: Ophthalmic
Date received: 2018-04-05
Decision date: 2018-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOQ

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K121738 — MYVISIONTRACK(TM)2013-02-22
K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)2002-03-04
K874252 — KREDA DISC1988-01-27
K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES1987-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.