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)

PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T

K-Number: K854471 · 1986-02-13

ApplicantMinnesota Laser Corp.
Decision Date1986-02-13
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Laser Corp.. It received FDA 510(k) clearance on 1986-02-13 under 510(k) number K854471. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T?

PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T is a medical device that received FDA 510(k) clearance on 1986-02-13. The listed applicant is Minnesota Laser Corp.. The 510(k) number is K854471.

When did PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T receive FDA 510(k) clearance?

PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T received FDA 510(k) clearance on 1986-02-13, under 510(k) number K854471.

Who is the listed applicant for PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T?

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

What is the FDA product code for PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T?

The FDA product code for PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T 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 Minnesota Laser Corp. 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.

K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSK854468PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGICK854473PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGICK854469PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG

View all 12 devices →

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.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 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.

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.

↑