FDA 510(k)

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

K番号: K180402 · 2018-05-25

決定日2018-05-25

製品コードHQF

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。 --- 当社の医療機器は、FDA（米国食品医薬品局）の510(k)規制に従って承認されています。PMA（プレマーケティングアセスメント）申請は、NCT（臨床試験登録番号）[NCTXXXXXXX]およびPMID（PubMed ID）[PMIDXXXXXXX]に基づいています。詳細については、以下のURLをご参照ください：[URL]。 --- Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてTopcon Medical Laser Systems, Inc.を記載するその他の記録

K171488PSLT for PASCAL Streamline

公式ソース

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