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)

DORC VITRECTOMY LENSES, MODEL 1284 SERIES

K-Number: K033950 · 2004-02-20

ApplicantDutch Ophthalmic Research Center (D.O.R.C.)
Decision Date2004-02-20
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DORC VITRECTOMY LENSES, MODEL 1284 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic Research Center (D.O.R.C.). It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K033950. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORC VITRECTOMY LENSES, MODEL 1284 SERIES?

DORC VITRECTOMY LENSES, MODEL 1284 SERIES is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Dutch Ophthalmic Research Center (D.O.R.C.). The 510(k) number is K033950.

When did DORC VITRECTOMY LENSES, MODEL 1284 SERIES receive FDA 510(k) clearance?

DORC VITRECTOMY LENSES, MODEL 1284 SERIES received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033950.

Who is the listed applicant for DORC VITRECTOMY LENSES, MODEL 1284 SERIES?

The FDA 510(k) record lists Dutch Ophthalmic Research Center (D.O.R.C.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORC VITRECTOMY LENSES, MODEL 1284 SERIES?

The FDA product code for DORC VITRECTOMY LENSES, MODEL 1284 SERIES is HJK.

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: HJK)

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.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFci Ophthalmics, 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.

↑