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)

OPHTIMPLANT

K-Number: K915630 · 1992-03-02

ApplicantOculo Plastik, Inc.
Decision Date1992-03-02
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTIMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Oculo Plastik, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915630. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTIMPLANT?

OPHTIMPLANT is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K915630.

When did OPHTIMPLANT receive FDA 510(k) clearance?

OPHTIMPLANT received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915630.

Who is the listed applicant for OPHTIMPLANT?

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

What is the FDA product code for OPHTIMPLANT?

The FDA product code for OPHTIMPLANT is HPZ.

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 Oculo Plastik, 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.

K123764DURETTE OCULAR IMPLANTK112176SILICONE SPHERESK073293DURETTE IMPLANTK040689EYE SPHERE IMPLANTSK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

View all 13 devices →

Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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.

↑