S2LO— 510(k) K981640

Substantially Equivalent

Odyssey Optical Systems, LLC

FDA 510(k) clearance K981640 for S2LO, Substantially Equivalent on 1998-08-05. Applicant: Odyssey Optical Systems, LLC. Device class: 2.

Clearance details

Applicant: Odyssey Optical Systems, LLC
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1998-05-08
Decision date: 1998-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLI

K153080 — RTVue XR OCT Avanti with AngioVue Software2016-02-11
K150722 — EnFocus 2300, EnFocus 44002015-12-02
K142953 — OCT-Camera2015-03-04
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2014-09-17
K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT2014-04-23

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