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FDA 510(k)

LASEREX LP1532 PHOTOCOAGULATOR

K-Number: K972514 · 1997-10-03

ApplicantEllex Medical Pty, Ltd.
Decision Date1997-10-03
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASEREX LP1532 PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K972514. 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 LASEREX LP1532 PHOTOCOAGULATOR?

LASEREX LP1532 PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K972514.

When did LASEREX LP1532 PHOTOCOAGULATOR receive FDA 510(k) clearance?

LASEREX LP1532 PHOTOCOAGULATOR received FDA 510(k) clearance on 1997-10-03, under 510(k) number K972514.

Who is the listed applicant for LASEREX LP1532 PHOTOCOAGULATOR?

The FDA 510(k) record lists Ellex Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASEREX LP1532 PHOTOCOAGULATOR?

The FDA product code for LASEREX LP1532 PHOTOCOAGULATOR is HQF.

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Other records listing Ellex Medical Pty, Ltd. 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.

K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoK212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloK190786Eye PrimeK122202ELLEX 2RTK081565INTEGRE PRO, MODEL L2RYK080423INTEGRE, MODEL LP581

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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.

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