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FDA 510(k)

SUPRA 577.Y LASER

K-Number: K091581 · 2009-06-16

ApplicantQuantel Medical
Decision Date2009-06-16
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUPRA 577.Y LASER is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2009-06-16 under 510(k) number K091581. 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 SUPRA 577.Y LASER?

SUPRA 577.Y LASER is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is Quantel Medical. The 510(k) number is K091581.

When did SUPRA 577.Y LASER receive FDA 510(k) clearance?

SUPRA 577.Y LASER received FDA 510(k) clearance on 2009-06-16, under 510(k) number K091581.

Who is the listed applicant for SUPRA 577.Y LASER?

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

What is the FDA product code for SUPRA 577.Y LASER?

The FDA product code for SUPRA 577.Y LASER is HQF.

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Other records listing Quantel Medical 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.

K251507INTEGRE LIOK232302Pocket IIIK220430CapsuloK213254Axialis Ophthalmic Ultrasound SystemK201502Vitra 810K191962Vitra 2

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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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