FDA 510(k)

울트라푸르스 수술 및 미용 CO2 레이저 시스템, 전달 장치 및 액세서리

K-번호: K203544 · 2020-12-24

결정일2020-12-24

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K203544. 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.

자주 묻는 질문

What is the UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Lumenis, Ltd.. The 510(k) number is K203544.

When did UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-12-24, under 510(k) number K203544.

Who is the listed applicant for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

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

What is the FDA product code for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.