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FDA 510(k)

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

K-Number: K170409 · 2017-09-12

ApplicantTopcon Medical Laser Systems, Inc. (Tmls)
Decision Date2017-09-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is a medical device manufactured by Topcon Medical Laser Systems, Inc. (Tmls). It received FDA 510(k) clearance on 2017-09-12 under approval 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.

Frequently Asked Questions

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. It is manufactured by Topcon Medical Laser Systems, Inc. (Tmls). The 510(k) number is K170409.

When was PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System approved by the FDA?

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

What company makes PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is manufactured by Topcon Medical Laser Systems, Inc. (Tmls).

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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