FDA 510(k)

S2LO

K-Number: K981640 · 1998-08-05

Decision Date1998-08-05

Product CodeHLI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

S2LO is the device name listed in this FDA 510(k) record. The listed applicant is Odyssey Optical Systems, LLC. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K981640. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S2LO?

S2LO is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Odyssey Optical Systems, LLC. The 510(k) number is K981640.

When did S2LO receive FDA 510(k) clearance?

S2LO received FDA 510(k) clearance on 1998-08-05, under 510(k) number K981640.

Who is the listed applicant for S2LO?

The FDA 510(k) record lists Odyssey Optical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S2LO?

The FDA product code for S2LO is HLI.

Related Devices (Code: HLI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KG K121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.