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FDA 510(k)

Q-PLUS T+ IPL LASER SYSTEM

K-Number: K123168 · 2012-12-20

ApplicantQuanta System Spa
Decision Date2012-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-PLUS T+ IPL LASER SYSTEM 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 2012-12-20 under 510(k) number K123168. 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 Q-PLUS T+ IPL LASER SYSTEM?

Q-PLUS T+ IPL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Quanta System Spa. The 510(k) number is K123168.

When did Q-PLUS T+ IPL LASER SYSTEM receive FDA 510(k) clearance?

Q-PLUS T+ IPL LASER SYSTEM received FDA 510(k) clearance on 2012-12-20, under 510(k) number K123168.

Who is the listed applicant for Q-PLUS T+ IPL LASER SYSTEM?

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 Q-PLUS T+ IPL LASER SYSTEM?

The FDA product code for Q-PLUS T+ IPL LASER SYSTEM 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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