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FDA 510(k)

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

Número K: K170409 · 2017-09-12

RequerenteTopcon Medical Laser Systems, Inc. (Tmls)
Data da decisão2017-09-12
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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