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FDA 510(k)

ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU

K-Number: K880808 · 1988-04-18

ApplicantCooper Lasersonics, Inc.
Decision Date1988-04-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880808. 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 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU?

ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K880808.

When did ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU receive FDA 510(k) clearance?

ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880808.

Who is the listed applicant for ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU?

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

What is the FDA product code for ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU?

The FDA product code for ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU is GEX. This falls under the Gastroenterology category.

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Other records listing Cooper Lasersonics, Inc. 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.

K880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SUK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880427ILLUMINA 40 CO2 LASER SYSTEMK880428ILLUMINA 25 CO2 LASER SYSTEMK880429ILLUMINA 55 CO2 LASER SYSTEMK880171MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL

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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

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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