ME-APDS; MAGENTIQ-COLO— 510(k) K223473

Substantially Equivalent

Magentiq Eye, Ltd.

FDA 510(k) clearance K223473 for ME-APDS; MAGENTIQ-COLO, Substantially Equivalent on 2023-07-25. Applicant: Magentiq Eye, Ltd.. Device class: 2.

Clearance details

Applicant: Magentiq Eye, Ltd.
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2022-11-17
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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K260724 — MAGENTIQ-COLO (ME-APDS)2026-04-03

More clearances from Magentiq Eye, Ltd.

K252178 — MAGENTIQ-COLO (ME-APDS)2025-10-03
K244023 — MAGENTIQ-COLO (ME-APDS)2025-01-24

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