FDA 510(k)

truSculpt

K号: K162512 · 2016-12-09

决定日期2016-12-09

产品代码PBX

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决定实质等同

器械摘要

truSculpt is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162512. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the truSculpt?

truSculpt is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Cutera, Inc.. The 510(k) number is K162512.

When did truSculpt receive FDA 510(k) clearance?

truSculpt received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162512.

Who is the listed applicant for truSculpt?

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?

The FDA product code for truSculpt is PBX.

列明Cutera, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251149AviClear激光系统 K233237xeo+ 家族 K230660AviClear激光系统 K223110truSculpt iD K221407truSculpt iD K213461AviClear激光系统

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官方来源

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