FDA 510(k)

PSLT 与 PASCAL Synthesis，PSLT 与 PASCAL Synthesis TwinStar

K号: K180402 · 2018-05-25

决定日期2018-05-25

产品代码HQF

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决定实质等同

器械摘要

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K180402. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar?

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K180402.

When did PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar receive FDA 510(k) clearance?

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180402.

Who is the listed applicant for PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar?

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

What is the FDA product code for PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar?

The FDA product code for PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar is HQF.

列明Topcon Medical Laser Systems, 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。

K171488PSLT 用于 PASCAL Streamline

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。