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

FDA 510(k)

PSLT for PASCAL Streamline

K-Number: K171488 · 2017-11-27

ApplicantTopcon Medical Laser Systems, Inc.
Decision Date2017-11-27
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PSLT for PASCAL Streamline 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 2017-11-27 under 510(k) number K171488. 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 for PASCAL Streamline?

PSLT for PASCAL Streamline is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K171488.

When did PSLT for PASCAL Streamline receive FDA 510(k) clearance?

PSLT for PASCAL Streamline received FDA 510(k) clearance on 2017-11-27, under 510(k) number K171488.

Who is the listed applicant for PSLT for PASCAL Streamline?

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 for PASCAL Streamline?

The FDA product code for PSLT for PASCAL Streamline is HQF.

Other records listing Topcon Medical Laser Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

Related Devices (Code: HQF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.

↑