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)

QUADRASPHERIC FUNDUS LENS

K-Number: K943125 · 1994-09-02

ApplicantVolk Optical, Inc.
Decision Date1994-09-02
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

QUADRASPHERIC FUNDUS LENS is the device name listed in this FDA 510(k) record. The listed applicant is Volk Optical, Inc.. It received FDA 510(k) clearance on 1994-09-02 under 510(k) number K943125. 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 QUADRASPHERIC FUNDUS LENS?

QUADRASPHERIC FUNDUS LENS is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Volk Optical, Inc.. The 510(k) number is K943125.

When did QUADRASPHERIC FUNDUS LENS receive FDA 510(k) clearance?

QUADRASPHERIC FUNDUS LENS received FDA 510(k) clearance on 1994-09-02, under 510(k) number K943125.

Who is the listed applicant for QUADRASPHERIC FUNDUS LENS?

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

What is the FDA product code for QUADRASPHERIC FUNDUS LENS?

The FDA product code for QUADRASPHERIC FUNDUS LENS 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

Other records listing Volk Optical, 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.

K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DK023221CONTACT LASER & DIAGNOSTIC LENSES

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.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

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.

↑