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)

PASCAL STREAMLINE PHOTOCOAGULATOR

K-Number: K092621 · 2009-09-25

ApplicantTopcon Medical Laser Systems, Inc.
Decision Date2009-09-25
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PASCAL STREAMLINE PHOTOCOAGULATOR 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 2009-09-25 under 510(k) number K092621. 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 PASCAL STREAMLINE PHOTOCOAGULATOR?

PASCAL STREAMLINE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K092621.

When did PASCAL STREAMLINE PHOTOCOAGULATOR receive FDA 510(k) clearance?

PASCAL STREAMLINE PHOTOCOAGULATOR received FDA 510(k) clearance on 2009-09-25, under 510(k) number K092621.

Who is the listed applicant for PASCAL STREAMLINE PHOTOCOAGULATOR?

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 PASCAL STREAMLINE PHOTOCOAGULATOR?

The FDA product code for PASCAL STREAMLINE PHOTOCOAGULATOR is HQF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TwinStarK171488PSLT for PASCAL StreamlineK123542PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERK111108PASCAL STREAMLINE 577 (WITH ACCESSORIES)K043486PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01

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.

↑