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FDA 510(k)

CLARITY II Laser System

K-Number: K183566 · 2019-06-14

ApplicantLutronic Corporation
Decision Date2019-06-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLARITY II Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K183566. 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 CLARITY II Laser System?

CLARITY II Laser System is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Lutronic Corporation. The 510(k) number is K183566.

When did CLARITY II Laser System receive FDA 510(k) clearance?

CLARITY II Laser System received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183566.

Who is the listed applicant for CLARITY II Laser System?

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

What is the FDA product code for CLARITY II Laser System?

The FDA product code for CLARITY II Laser System is GEX. This falls under the Gastroenterology category.

Other records listing Lutronic Corporation as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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