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FDA 510(k)

Spirit Hair Removal laser Family

K-Number: K153718 · 2016-02-12

ApplicantActive Optical Systems , Ltd.
Decision Date2016-02-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Spirit Hair Removal laser Family is a medical device manufactured by Active Optical Systems , Ltd.. It received FDA 510(k) clearance on 2016-02-12 under approval number K153718. 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 Spirit Hair Removal laser Family?

Spirit Hair Removal laser Family is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Active Optical Systems , Ltd.. The 510(k) number is K153718.

When was Spirit Hair Removal laser Family approved by the FDA?

Spirit Hair Removal laser Family received FDA 510(k) clearance on 2016-02-12, under approval number K153718.

What company makes Spirit Hair Removal laser Family?

Spirit Hair Removal laser Family is manufactured by Active Optical Systems , Ltd..

What is the FDA product code for Spirit Hair Removal laser Family?

The FDA product code for Spirit Hair Removal laser Family 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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