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FDA 510(k)

LASER IRAS

K-Number: K853556 · 1985-11-01

ApplicantRandwal Instrument Co., Inc.
Decision Date1985-11-01
Product CodeHPJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASER IRAS is the device name listed in this FDA 510(k) record. The listed applicant is Randwal Instrument Co., Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853556. The device is classified under product code HPJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER IRAS?

LASER IRAS is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Randwal Instrument Co., Inc.. The 510(k) number is K853556.

When did LASER IRAS receive FDA 510(k) clearance?

LASER IRAS received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853556.

Who is the listed applicant for LASER IRAS?

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

What is the FDA product code for LASER IRAS?

The FDA product code for LASER IRAS is HPJ.

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 Randwal Instrument Co., 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.

K873990IRAS EDS INTERFEROMETRIC STIMULATORK873987IRAS GLARE TESTERK864012IRAS PERIMETERK842567PORTABLE ACUIOMETERK827577VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

Related Devices (Code: HPJ)

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.

K864012IRAS PERIMETERRandwal Instrument Co., Inc.K822415THE OCUPLOT DCoherent Medical DivisionK813429LASER PHOTOCOAGULATOR ARGON MED. LASERAmerican Laser Corp.K781507RETINOMETERCoburn Optical Ind., 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.

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