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FDA 510(k)

SculpSure

K号: K182741 · 2019-01-03

申请人Cynosure
决定日期2019-01-03
产品代码PKT
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决定实质等同

器械摘要

SculpSure is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K182741. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SculpSure?

SculpSure is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Cynosure. The 510(k) number is K182741.

When did SculpSure receive FDA 510(k) clearance?

SculpSure received FDA 510(k) clearance on 2019-01-03, under 510(k) number K182741.

Who is the listed applicant for SculpSure?

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

What is the FDA product code for SculpSure?

The FDA product code for SculpSure is PKT.

相关临床试验

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相关器械(代码:PKT)

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。

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