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FDA 510(k)

HEINE OMEGA 500

K-Number: K123316 · 2013-02-26

ApplicantHeine Optotechnik GmbH & Co. KG
Decision Date2013-02-26
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEINE OMEGA 500 is the device name listed in this FDA 510(k) record. The listed applicant is Heine Optotechnik GmbH & Co. KG. It received FDA 510(k) clearance on 2013-02-26 under 510(k) number K123316. 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 HEINE OMEGA 500?

HEINE OMEGA 500 is a medical device that received FDA 510(k) clearance on 2013-02-26. The listed applicant is Heine Optotechnik GmbH & Co. KG. The 510(k) number is K123316.

When did HEINE OMEGA 500 receive FDA 510(k) clearance?

HEINE OMEGA 500 received FDA 510(k) clearance on 2013-02-26, under 510(k) number K123316.

Who is the listed applicant for HEINE OMEGA 500?

The FDA 510(k) record lists Heine Optotechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEINE OMEGA 500?

The FDA product code for HEINE OMEGA 500 is HLI.

Related Clinical Trials

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Other records listing Heine Optotechnik GmbH & Co. KG as applicant

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.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEK123587HEINE MINI 3000 LED OPHTHALMOSCOPEK101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

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.K121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.K103266ISTANDOptovue, Inc.

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.

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