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FDA 510(k)

MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)

K-Number: K860831 · 1986-10-02

ApplicantCooper Lasersonics, Inc.
Decision Date1986-10-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) 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 1986-10-02 under 510(k) number K860831. 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 MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)?

MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K860831.

When did MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) receive FDA 510(k) clearance?

MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) received FDA 510(k) clearance on 1986-10-02, under 510(k) number K860831.

Who is the listed applicant for MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)?

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-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)?

The FDA product code for MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) is GEX. This falls under the Gastroenterology category.

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Other records listing Cooper Lasersonics, Inc. as applicant

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Related Devices (Code: GEX)

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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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