FDA 510(k)

U.S. Laser Worx Patriot 1 family of lasers

Numéro K : K162334 · 2017-04-27

Date de décision2017-04-27

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

U.S. Laser Worx Patriot 1 family of lasers is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Laser Worx. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K162334. 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.

Questions fréquentes

What is the U.S. Laser Worx Patriot 1 family of lasers?

U.S. Laser Worx Patriot 1 family of lasers is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is U.S. Laser Worx. The 510(k) number is K162334.

When did U.S. Laser Worx Patriot 1 family of lasers receive FDA 510(k) clearance?

U.S. Laser Worx Patriot 1 family of lasers received FDA 510(k) clearance on 2017-04-27, under 510(k) number K162334.

Who is the listed applicant for U.S. Laser Worx Patriot 1 family of lasers?

The FDA 510(k) record lists U.S. Laser Worx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U.S. Laser Worx Patriot 1 family of lasers?

The FDA product code for U.S. Laser Worx Patriot 1 family of lasers is GEX. This falls under the Gastroenterology category.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.