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FDA 510(k)

MODEL LS 860, CO2 LASER

K-Number: K864562 · 1987-04-09

ApplicantCooper Lasersonics, Inc.
Decision Date1987-04-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODEL LS 860, CO2 LASER 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 1987-04-09 under 510(k) number K864562. 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 for Some Indications.

Frequently Asked Questions

What is the MODEL LS 860, CO2 LASER?

MODEL LS 860, CO2 LASER is a medical device that received FDA 510(k) clearance on 1987-04-09. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K864562.

When did MODEL LS 860, CO2 LASER receive FDA 510(k) clearance?

MODEL LS 860, CO2 LASER received FDA 510(k) clearance on 1987-04-09, under 510(k) number K864562.

Who is the listed applicant for MODEL LS 860, CO2 LASER?

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 MODEL LS 860, CO2 LASER?

The FDA product code for MODEL LS 860, CO2 LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Cooper Lasersonics, Inc. as applicant

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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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