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FDA 510(k)

MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT

K-Number: K850779 · 1985-04-02

ApplicantCooper Lasersonics, Inc.
Decision Date1985-04-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT 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 1985-04-02 under 510(k) number K850779. 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 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT?

MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT is a medical device that received FDA 510(k) clearance on 1985-04-02. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K850779.

When did MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT receive FDA 510(k) clearance?

MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT received FDA 510(k) clearance on 1985-04-02, under 510(k) number K850779.

Who is the listed applicant for MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT?

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 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT?

The FDA product code for MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT 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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