Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS

K-Number: K851264 · 1985-05-01

ApplicantAmerican Medical Optics
Decision Date1985-05-01
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K851264. 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 AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS?

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is American Medical Optics. The 510(k) number is K851264.

When did AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS receive FDA 510(k) clearance?

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS received FDA 510(k) clearance on 1985-05-01, under 510(k) number K851264.

Who is the listed applicant for AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS?

The FDA 510(k) record lists American Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS?

The FDA product code for AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS is HLI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Medical Optics 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.

K860001BARRAQUER-KRUMEICH REFRACTIVE SETK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYSK843965ARGON LASER PHOTOCOAGULATOR SYS

View all 17 devices →

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.

↑