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FDA 510(k)

PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC

K-Number: K854468 · 1986-06-20

ApplicantMinnesota Laser Corp.
Decision Date1986-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC 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 1986-06-20 under 510(k) number K854468. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC?

PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC is a medical device that received FDA 510(k) clearance on 1986-06-20. The listed applicant is Minnesota Laser Corp.. The 510(k) number is K854468.

When did PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC receive FDA 510(k) clearance?

PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC received FDA 510(k) clearance on 1986-06-20, under 510(k) number K854468.

Who is the listed applicant for PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC?

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 DIOXIDE SURG LASER NEUROLOGIC?

The FDA product code for PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC is GEX. This falls under the Gastroenterology category.

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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 APPLICATIONSK854473PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGICK854471PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/TK854469PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG

View all 12 devices →

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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