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FDA 510(k)

PASCAL STREAMLINE 577 (WITH ACCESSORIES)

K-Number: K111108 · 2011-08-11

ApplicantTopcon Medical Laser Systems, Inc.
Decision Date2011-08-11
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PASCAL STREAMLINE 577 (WITH ACCESSORIES) 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 2011-08-11 under 510(k) number K111108. 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 577 (WITH ACCESSORIES)?

PASCAL STREAMLINE 577 (WITH ACCESSORIES) is a medical device that received FDA 510(k) clearance on 2011-08-11. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K111108.

When did PASCAL STREAMLINE 577 (WITH ACCESSORIES) receive FDA 510(k) clearance?

PASCAL STREAMLINE 577 (WITH ACCESSORIES) received FDA 510(k) clearance on 2011-08-11, under 510(k) number K111108.

Who is the listed applicant for PASCAL STREAMLINE 577 (WITH ACCESSORIES)?

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 577 (WITH ACCESSORIES)?

The FDA product code for PASCAL STREAMLINE 577 (WITH ACCESSORIES) 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.

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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 LASERK092621PASCAL STREAMLINE PHOTOCOAGULATORK043486PASCAL 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

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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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