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FDA 510(k)

MODEL 150K LASER COAGULATOR

K-Number: K832089 · 1984-01-30

ApplicantLasertek OY
Decision Date1984-01-30
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 150K LASER COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lasertek OY. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K832089. 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 MODEL 150K LASER COAGULATOR?

MODEL 150K LASER COAGULATOR is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Lasertek OY. The 510(k) number is K832089.

When did MODEL 150K LASER COAGULATOR receive FDA 510(k) clearance?

MODEL 150K LASER COAGULATOR received FDA 510(k) clearance on 1984-01-30, under 510(k) number K832089.

Who is the listed applicant for MODEL 150K LASER COAGULATOR?

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

What is the FDA product code for MODEL 150K LASER COAGULATOR?

The FDA product code for MODEL 150K LASER COAGULATOR 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 Lasertek OY 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.

K828326UNKNOWNK782106COAGULATOR, MODEL 40 AARGONK781965LASER COAGULATOR, MODEL 41AK

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.

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