Phoenix ICON, Phoenix ICON GO— 510(k) K223575

Substantially Equivalent

Neolight, LLC

FDA 510(k) clearance K223575 for Phoenix ICON, Phoenix ICON GO, Substantially Equivalent on 2023-09-06. Applicant: Neolight, LLC. Device class: 2.

Clearance details

Applicant: Neolight, LLC
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2022-11-30
Decision date: 2023-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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