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FDA 510(k)

MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER

K-Number: K921298 · 1992-07-02

ApplicantCj Laser Corp.
Decision Date1992-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cj Laser Corp.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K921298. 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 MM-2405 AND MM-2410 COPPER VAPOR LASER?

MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Cj Laser Corp.. The 510(k) number is K921298.

When did MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER receive FDA 510(k) clearance?

MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921298.

Who is the listed applicant for MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER?

The FDA 510(k) record lists Cj Laser Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER?

The FDA product code for MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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