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)

ARGON/KRYPTON ION LASER PHOTOCOAGULA

K-Number: K834305 · 1984-03-16

ApplicantNidek, Inc.
Decision Date1984-03-16
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARGON/KRYPTON ION LASER PHOTOCOAGULA is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834305. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGON/KRYPTON ION LASER PHOTOCOAGULA?

ARGON/KRYPTON ION LASER PHOTOCOAGULA is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Nidek, Inc.. The 510(k) number is K834305.

When did ARGON/KRYPTON ION LASER PHOTOCOAGULA receive FDA 510(k) clearance?

ARGON/KRYPTON ION LASER PHOTOCOAGULA received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834305.

Who is the listed applicant for ARGON/KRYPTON ION LASER PHOTOCOAGULA?

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

What is the FDA product code for ARGON/KRYPTON ION LASER PHOTOCOAGULA?

The FDA product code for ARGON/KRYPTON ION LASER PHOTOCOAGULA is HQF.

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 Nidek, 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

View all 77 devices →

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.

↑