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FDA 510(k)

VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES

K-Number: K063396 · 2007-01-17

ApplicantLasering S.R.L.
Decision Date2007-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lasering S.R.L.. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K063396. 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 VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES?

VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is Lasering S.R.L.. The 510(k) number is K063396.

When did VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES receive FDA 510(k) clearance?

VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES received FDA 510(k) clearance on 2007-01-17, under 510(k) number K063396.

Who is the listed applicant for VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES?

The FDA 510(k) record lists Lasering S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES?

The FDA product code for VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Lasering S.R.L. 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.

K110984SLIM E30 II CO2 LASERK063001SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES

Related Devices (Code: GEX)

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

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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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