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FDA 510(k)

LASERMATIC SURGILASER MODEL 5050

K-Number: K870587 · 1988-08-10

ApplicantLasermatic OY
Decision Date1988-08-10
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent for Some Indications

Device Summary

LASERMATIC SURGILASER MODEL 5050 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermatic OY. It received FDA 510(k) clearance on 1988-08-10 under 510(k) number K870587. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LASERMATIC SURGILASER MODEL 5050?

LASERMATIC SURGILASER MODEL 5050 is a medical device that received FDA 510(k) clearance on 1988-08-10. The listed applicant is Lasermatic OY. The 510(k) number is K870587.

When did LASERMATIC SURGILASER MODEL 5050 receive FDA 510(k) clearance?

LASERMATIC SURGILASER MODEL 5050 received FDA 510(k) clearance on 1988-08-10, under 510(k) number K870587.

Who is the listed applicant for LASERMATIC SURGILASER MODEL 5050?

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

What is the FDA product code for LASERMATIC SURGILASER MODEL 5050?

The FDA product code for LASERMATIC SURGILASER MODEL 5050 is EWG.

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 Lasermatic 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.

K895279LASERMATIC COMBOLASER MODEL 5050

Related Devices (Code: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, Inc.K870840MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHDirected Energy, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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