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FDA 510(k)

CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.

K-Number: K883488 · 1988-12-19

ApplicantHeraeus Lasersonics, Inc.
Decision Date1988-12-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Lasersonics, Inc.. It received FDA 510(k) clearance on 1988-12-19 under 510(k) number K883488. 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 CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.?

CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. is a medical device that received FDA 510(k) clearance on 1988-12-19. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K883488.

When did CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. receive FDA 510(k) clearance?

CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. received FDA 510(k) clearance on 1988-12-19, under 510(k) number K883488.

Who is the listed applicant for CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.?

The FDA 510(k) record lists Heraeus Lasersonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.?

The FDA product code for CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. is GEX. This falls under the Gastroenterology category.

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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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