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FDA 510(k)

OCT-OPTHALMOSCOPE

K-Number: K042885 · 2005-01-21

ApplicantOphthalmic Technologies, Inc.
Decision Date2005-01-21
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCT-OPTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Technologies, Inc.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K042885. 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 OCT-OPTHALMOSCOPE?

OCT-OPTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K042885.

When did OCT-OPTHALMOSCOPE receive FDA 510(k) clearance?

OCT-OPTHALMOSCOPE received FDA 510(k) clearance on 2005-01-21, under 510(k) number K042885.

Who is the listed applicant for OCT-OPTHALMOSCOPE?

The FDA 510(k) record lists Ophthalmic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCT-OPTHALMOSCOPE?

The FDA product code for OCT-OPTHALMOSCOPE is HLI.

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Other records listing Ophthalmic Technologies, Inc. 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.

K031391HF MODULE WITH TRANSDUCERSK030770OTI SCAN WITH TRANSDUCERSK024114A-SCAN 100K990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMK9745223D I-SCANK971679I-SCOPE OPHTHALMIC ENDOSCOPE

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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. KGK121739IVUE 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.

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