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FDA 510(k)

PASCAL 合成 Twinstar 眼科掃描雷射系統

K 號：K170409 · 2017-09-12

申請人Topcon Medical Laser Systems, Inc. (Tmls)
決定日期2017-09-12
產品代碼GEX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Laser Systems, Inc. (Tmls). It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K170409. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Topcon Medical Laser Systems, Inc. (Tmls). The 510(k) number is K170409.

When did PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System receive FDA 510(k) clearance?

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System received FDA 510(k) clearance on 2017-09-12, under 510(k) number K170409.

Who is the listed applicant for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

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

What is the FDA product code for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

The FDA product code for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is GEX. This falls under the Gastroenterology category.

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