FDA 510(k)

Alma FemiLift Pixel Sistema de Laser CO2, Dispositivos de Entrega y Accesorios

N.º K: K250071 · 2025-09-24

Fecha de decisión2025-09-24

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K250071. 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.

Preguntas frecuentes

What is the Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K250071.

When did Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2025-09-24, under 510(k) number K250071.

Who is the listed applicant for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

The FDA 510(k) record lists Alma Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Alma Lasers, Inc. como solicitante

K251684Alma TED+ Sistema K251230The Alma Hybrid Laser System K243044Alma Harmony K233024Alma Harmony K230308Alma Harmony K230371The Alma Soprano Titanium

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.