iCare HOME2— 510(k) K211355

Substantially Equivalent

Icare Finland OY

FDA 510(k) clearance K211355 for iCare HOME2, Substantially Equivalent on 2022-01-25. Applicant: Icare Finland OY.

Clearance details

Applicant: Icare Finland OY
Product code: Code HKY
Advisory panel: Ophthalmic
Date received: 2021-05-03
Decision date: 2022-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

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