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FDA 510(k)

SIROLaser Advance+

K-Number: K170500 · 2017-05-16

ApplicantDentsply Sirona
Decision Date2017-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIROLaser Advance+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170500. 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 SIROLaser Advance+?

SIROLaser Advance+ is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Dentsply Sirona. The 510(k) number is K170500.

When did SIROLaser Advance+ receive FDA 510(k) clearance?

SIROLaser Advance+ received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170500.

Who is the listed applicant for SIROLaser Advance+?

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

What is the FDA product code for SIROLaser Advance+?

The FDA product code for SIROLaser Advance+ 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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