FDA 510(k)

Diode-Laser-Haarentfernungssysteme für medizinische Anwendung (Modelle: Milestone Smart-M, Milestone Standard-A)

K-Nummer: K222800 · 2022-11-07

AntragstellerSanhe Laserconn Tech Co., Ltd.

Entscheidungsdatum2022-11-07

ProduktcodeGEX

BeratungsausschussSU I'm sorry, but it seems like the text you provided is incomplete. Could you please provide the full description or text that you would like translated into German?

EntscheidungSubstantiell Äquivalent

Produktübersicht

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe Laserconn Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) 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.

Häufig gestellte Fragen

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. The listed applicant is Sanhe Laserconn Tech Co., Ltd.. The 510(k) number is K222800.

When did Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) receive FDA 510(k) clearance?

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 510(k) number K222800.

Who is the listed applicant for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

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

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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Offizielle Quelle

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