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FDA 510(k)

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

K-Number: K123542 · 2013-05-15

ApplicantTopcon Medical Laser Systems, Inc.
Decision Date2013-05-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER 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 2013-05-15 under 510(k) number K123542. 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 SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Topcon Medical Laser Systems, Inc.. The 510(k) number is K123542.

When did PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER receive FDA 510(k) clearance?

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER received FDA 510(k) clearance on 2013-05-15, under 510(k) number K123542.

Who is the listed applicant for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

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 SYNTHESIS (532NM/577NM) OPTHALMIC LASER?

The FDA product code for PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER 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 StreamlineK111108PASCAL STREAMLINE 577 (WITH ACCESSORIES)K092621PASCAL 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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