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FDA 510(k)

MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT

K-Number: K895348 · 1989-10-20

ApplicantLasag Medical Lasers
Decision Date1989-10-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Lasag Medical Lasers. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K895348. 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 MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT?

MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Lasag Medical Lasers. The 510(k) number is K895348.

When did MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT receive FDA 510(k) clearance?

MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT received FDA 510(k) clearance on 1989-10-20, under 510(k) number K895348.

Who is the listed applicant for MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT?

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

What is the FDA product code for MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT?

The FDA product code for MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT is GEX. This falls under the Gastroenterology category.

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 Lasag Medical Lasers 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.

K895347MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT

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.

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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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