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FDA 510(k)

COMPAC(TM) DIODE LASERS

K-Number: K904699 · 1991-04-25

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1991-04-25
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPAC(TM) DIODE LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K904699. 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 COMPAC(TM) DIODE LASERS?

COMPAC(TM) DIODE LASERS is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K904699.

When did COMPAC(TM) DIODE LASERS receive FDA 510(k) clearance?

COMPAC(TM) DIODE LASERS received FDA 510(k) clearance on 1991-04-25, under 510(k) number K904699.

Who is the listed applicant for COMPAC(TM) DIODE LASERS?

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

What is the FDA product code for COMPAC(TM) DIODE LASERS?

The FDA product code for COMPAC(TM) DIODE LASERS is HQF.

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Other records listing Hgm 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.

K921300MODEL PC ARGON ION LASERK914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK912438MODELS 5,8,20,20S ARGON ION LASERS

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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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