FDA 510(k)

iRestore 专业版 282

K号: K183417 · 2019-05-17

决定日期2019-05-17

产品代码OAP

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决定实质等同

器械摘要

iRestore Professional 282 is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K183417. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iRestore Professional 282?

iRestore Professional 282 is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K183417.

When did iRestore Professional 282 receive FDA 510(k) clearance?

iRestore Professional 282 received FDA 510(k) clearance on 2019-05-17, under 510(k) number K183417.

Who is the listed applicant for iRestore Professional 282?

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

What is the FDA product code for iRestore Professional 282?

The FDA product code for iRestore Professional 282 is OAP.

列明Freedom Laser Therapy, 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。

K222081ID-510 iRestore精英版 K213094ID-500 iRestore生发系统 K151662iRestore

相关器械（代码：OAP）

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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