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FDA 510(k)

COPPER VAPOR LASER SYSTEM

K-Number: K915370 · 1992-02-07

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

Device Summary

COPPER VAPOR LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metatech Corp.. It received FDA 510(k) clearance on 1992-02-07 under 510(k) number K915370. 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 COPPER VAPOR LASER SYSTEM?

COPPER VAPOR LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-07. The listed applicant is Metatech Corp.. The 510(k) number is K915370.

When did COPPER VAPOR LASER SYSTEM receive FDA 510(k) clearance?

COPPER VAPOR LASER SYSTEM received FDA 510(k) clearance on 1992-02-07, under 510(k) number K915370.

Who is the listed applicant for COPPER VAPOR LASER SYSTEM?

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

What is the FDA product code for COPPER VAPOR LASER SYSTEM?

The FDA product code for COPPER VAPOR LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Metatech Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K924314MOBILE STANDING FRAMEK903883VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LESK890865HEXASCAN SCANNER HANDPIECEK883541METALASER VASCULASEK883881MODIFIED MODEL 2001 FIBER OPTICS CATHETERK883518EVENT MARKER & A SECOND PRESSURE TREND OUTPUT

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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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