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FDA 510(k)

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

K-Number: K170179 · 2017-09-18

ApplicantLumenis, Ltd.
Decision Date2017-09-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K170179. 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 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Lumenis, Ltd.. The 510(k) number is K170179.

When did LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity receive FDA 510(k) clearance?

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity received FDA 510(k) clearance on 2017-09-18, under 510(k) number K170179.

Who is the listed applicant for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

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

What is the FDA product code for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

The FDA product code for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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