Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

K-Number: K180402 · 2018-05-25

ApplicantTopcon Medical Laser Systems, Inc.
Decision Date2018-05-25
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Topcon Medical Laser Systems, Inc.. The 510(k) number is K180402.

When was PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar approved by the FDA?

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

What company makes PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar?

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar is manufactured by Topcon Medical Laser Systems, Inc..

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.

Other Devices by Topcon Medical Laser Systems, Inc.

K171488PSLT for PASCAL Streamline

Related Devices (Code: HQF)

K153769R:GEN Laser SystemLutronic Corporation K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. K170067EasyretQuantel Medical K170302YELLOW LASER PHOTOCOAGULATOR YLC-500Nidek Co., Ltd.

Official Source

View on FDA Database →

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

↑