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FDA 510(k)

PORTALASE 200 CARBON SURGICAL LASER SYSTEM

K-Number: K852694 · 1985-09-30

ApplicantMinnesota Laser Corp.
Decision Date1985-09-30
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent for Some Indications

Device Summary

PORTALASE 200 CARBON SURGICAL LASER SYSTEM 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 1985-09-30 under 510(k) number K852694. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PORTALASE 200 CARBON SURGICAL LASER SYSTEM?

PORTALASE 200 CARBON SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-30. The listed applicant is Minnesota Laser Corp.. The 510(k) number is K852694.

When did PORTALASE 200 CARBON SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

PORTALASE 200 CARBON SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1985-09-30, under 510(k) number K852694.

Who is the listed applicant for PORTALASE 200 CARBON SURGICAL LASER SYSTEM?

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 200 CARBON SURGICAL LASER SYSTEM?

The FDA product code for PORTALASE 200 CARBON SURGICAL LASER SYSTEM is HHR.

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.

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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 NEUROLOGICK854471PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T

View all 12 devices →

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, 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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