FDA 510(k)

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

K-Nummer: K251339 · 2025-07-25

AntragstellerZhengzhou PZ Laser Slim Technology Co., Ltd.

Entscheidungsdatum2025-07-25

ProduktcodeGEX

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K251339. 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 Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K251339.

When did Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) receive FDA 510(k) clearance?

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) received FDA 510(k) clearance on 2025-07-25, under 510(k) number K251339.

Who is the listed applicant for Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)?

The FDA product code for Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is GEX. This falls under the Gastroenterology category.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Zhengzhou PZ Laser Slim Technology Co., Ltd. als Antragsteller

K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)K250782Fractional CO2 Laser Machine

Alle 10 Geräte anzeigen →

Verwandte Geräte (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.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.