Softcure 96
K号: K170068 · 2017-05-05
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决定日期2017-05-05
产品代码ILY
咨询委员会PM
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决定实质等同
器械摘要
Softcure 96 is the device name listed in this FDA 510(k) record. The listed applicant is Wellray Medical Laser, Inc.. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K170068. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Softcure 96?
Softcure 96 is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Wellray Medical Laser, Inc.. The 510(k) number is K170068.
When did Softcure 96 receive FDA 510(k) clearance?
Softcure 96 received FDA 510(k) clearance on 2017-05-05, under 510(k) number K170068.
Who is the listed applicant for Softcure 96?
The FDA 510(k) record lists Wellray Medical Laser, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Softcure 96?
The FDA product code for Softcure 96 is ILY.
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相关器械（代码：ILY）
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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官方来源
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