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FDA 510(k)

QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY

K-Number: K083613 · 2008-12-23

ApplicantQuanta System Spa
Decision Date2008-12-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083613. 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 QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY?

QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Quanta System Spa. The 510(k) number is K083613.

When did QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY receive FDA 510(k) clearance?

QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083613.

Who is the listed applicant for QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY?

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

What is the FDA product code for QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY?

The FDA product code for QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY is GEX. This falls under the Gastroenterology category.

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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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