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FDA 510(k)

VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES

K-Number: K903883 · 1990-09-19

ApplicantMetatech Corp.
Decision Date1990-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES is the device name listed in this FDA 510(k) record. The listed applicant is Metatech Corp.. It received FDA 510(k) clearance on 1990-09-19 under 510(k) number K903883. 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 VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES?

VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES is a medical device that received FDA 510(k) clearance on 1990-09-19. The listed applicant is Metatech Corp.. The 510(k) number is K903883.

When did VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES receive FDA 510(k) clearance?

VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES received FDA 510(k) clearance on 1990-09-19, under 510(k) number K903883.

Who is the listed applicant for VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES?

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 VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES?

The FDA product code for VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES 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.

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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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