FDA 510(k)

2940 nm Er:Yag Laser Handpiece

K-Number: K173002 · 2017-12-13

Decision Date2017-12-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

2940 nm Er:Yag Laser Handpiece 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 2017-12-13 under 510(k) number K173002. 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 2940 nm Er:Yag Laser Handpiece?

2940 nm Er:Yag Laser Handpiece is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Quanta System Spa. The 510(k) number is K173002.

When did 2940 nm Er:Yag Laser Handpiece receive FDA 510(k) clearance?

2940 nm Er:Yag Laser Handpiece received FDA 510(k) clearance on 2017-12-13, under 510(k) number K173002.

Who is the listed applicant for 2940 nm Er:Yag Laser Handpiece?

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 2940 nm Er:Yag Laser Handpiece?

The FDA product code for 2940 nm Er:Yag Laser Handpiece is GEX. This falls under the Gastroenterology category.

Other records listing Quanta System Spa as applicant

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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.