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FDA 510(k)

PASCAL LASER INDIRECT OPHTHALMOSCOPE

K-Number: K123056 · 2012-11-13

ApplicantTopcon Medical Laser Systems, Inc. (Tmls)
Decision Date2012-11-13
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PASCAL LASER INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Laser Systems, Inc. (Tmls). It received FDA 510(k) clearance on 2012-11-13 under 510(k) number K123056. 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 LASER INDIRECT OPHTHALMOSCOPE?

PASCAL LASER INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2012-11-13. The listed applicant is Topcon Medical Laser Systems, Inc. (Tmls). The 510(k) number is K123056.

When did PASCAL LASER INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

PASCAL LASER INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 2012-11-13, under 510(k) number K123056.

Who is the listed applicant for PASCAL LASER INDIRECT OPHTHALMOSCOPE?

The FDA 510(k) record lists Topcon Medical Laser Systems, Inc. (Tmls) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASCAL LASER INDIRECT OPHTHALMOSCOPE?

The FDA product code for PASCAL LASER INDIRECT OPHTHALMOSCOPE is HQF.

Related Clinical Trials

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Other records listing Topcon Medical Laser Systems, Inc. (Tmls) 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.

K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

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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