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FDA 510(k)

COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY

K-Number: K851000 · 1985-08-14

ApplicantCooper Lasersonics, Inc.
Decision Date1985-08-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY 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 1985-08-14 under 510(k) number K851000. 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 COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY?

COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY is a medical device that received FDA 510(k) clearance on 1985-08-14. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K851000.

When did COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY receive FDA 510(k) clearance?

COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY received FDA 510(k) clearance on 1985-08-14, under 510(k) number K851000.

Who is the listed applicant for COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY?

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 COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY?

The FDA product code for COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY 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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