FDA 510(k)

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

K-Number: K222800 · 2022-11-07

Decision Date2022-11-07

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is a medical device manufactured by Sanhe Laserconn Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-11-07 under approval number K222800. 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 Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Sanhe Laserconn Tech Co., Ltd.. The 510(k) number is K222800.

When was Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) approved by the FDA?

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) received FDA 510(k) clearance on 2022-11-07, under approval number K222800.

What company makes Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is manufactured by Sanhe Laserconn Tech Co., Ltd..

What is the FDA product code for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

The FDA product code for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is GEX. This falls under the Gastroenterology category.

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Official Source

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