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)

CUSTOM OCULAR PROSTHESIS

K-Number: K946226 · 1995-03-22

ApplicantFrank Tanaka, Ocularist, Inc.
Decision Date1995-03-22
Product CodeHQH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CUSTOM OCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Frank Tanaka, Ocularist, Inc.. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K946226. The device is classified under product code HQH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM OCULAR PROSTHESIS?

CUSTOM OCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Frank Tanaka, Ocularist, Inc.. The 510(k) number is K946226.

When did CUSTOM OCULAR PROSTHESIS receive FDA 510(k) clearance?

CUSTOM OCULAR PROSTHESIS received FDA 510(k) clearance on 1995-03-22, under 510(k) number K946226.

Who is the listed applicant for CUSTOM OCULAR PROSTHESIS?

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

What is the FDA product code for CUSTOM OCULAR PROSTHESIS?

The FDA product code for CUSTOM OCULAR PROSTHESIS is HQH.

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

Related Devices (Code: HQH)

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.

K952538ROBERT B. SCOTT PLASTIC ARTIFICALRobert B. Scott Ocularists of Florida, Inc.K945270CUSTOM ARTIFICIAL HUMAN EYESDaniel T AcostaK923167THE NISSEL ARTIFICIAL EYENissel , Ltd.K904962EYE ARTIFICIAL CUSTOMMidwest Eye Laboratories, Inc.K791923SCLERAL POWDEROcularists , Ltd.

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.

↑