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FDA 510(k)

SIROLaser Blue

K-Number: K180044 · 2018-03-08

ApplicantDentsply Sirona
Decision Date2018-03-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIROLaser Blue is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K180044. 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 Blue?

SIROLaser Blue is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Dentsply Sirona. The 510(k) number is K180044.

When did SIROLaser Blue receive FDA 510(k) clearance?

SIROLaser Blue received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180044.

Who is the listed applicant for SIROLaser Blue?

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 Blue?

The FDA product code for SIROLaser Blue 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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