FDA 510(k)

truSculpt RF 장치; truSculpt; truSculpt 3D

K-번호: K180709 · 2018-06-06

결정일2018-06-06

제품 코드PBX

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

결정대체적으로 동일

기기 요약

truSculpt RF Device; truSculpt; truSculpt 3D is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180709. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the truSculpt RF Device; truSculpt; truSculpt 3D?

truSculpt RF Device; truSculpt; truSculpt 3D is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Cutera, Inc.. The 510(k) number is K180709.

When did truSculpt RF Device; truSculpt; truSculpt 3D receive FDA 510(k) clearance?

truSculpt RF Device; truSculpt; truSculpt 3D received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180709.

Who is the listed applicant for truSculpt RF Device; truSculpt; truSculpt 3D?

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

What is the FDA product code for truSculpt RF Device; truSculpt; truSculpt 3D?

The FDA product code for truSculpt RF Device; truSculpt; truSculpt 3D is PBX.

Cutera, Inc.를 신청인으로 등재한 기타 기록

K251149아비클리어 레이저 시스템 K233237xeo+ 가족 K230660아비클리어 레이저 시스템 K223110truSculpt iD K221407truSculpt iD K213461아비클리어 레이저 시스템

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