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FDA 510(k)

CANDELA DIODE TRABECULOPLASTY LASER DTL

K-Number: K910612 · 1991-03-04

ApplicantCandela Laser Corp.
Decision Date1991-03-04
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANDELA DIODE TRABECULOPLASTY LASER DTL is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1991-03-04 under 510(k) number K910612. 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 CANDELA DIODE TRABECULOPLASTY LASER DTL?

CANDELA DIODE TRABECULOPLASTY LASER DTL is a medical device that received FDA 510(k) clearance on 1991-03-04. The listed applicant is Candela Laser Corp.. The 510(k) number is K910612.

When did CANDELA DIODE TRABECULOPLASTY LASER DTL receive FDA 510(k) clearance?

CANDELA DIODE TRABECULOPLASTY LASER DTL received FDA 510(k) clearance on 1991-03-04, under 510(k) number K910612.

Who is the listed applicant for CANDELA DIODE TRABECULOPLASTY LASER DTL?

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

What is the FDA product code for CANDELA DIODE TRABECULOPLASTY LASER DTL?

The FDA product code for CANDELA DIODE TRABECULOPLASTY LASER DTL is HQF.

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Other records listing Candela Laser Corp. 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.

K951033ANDELA DYNAMIC COOLING DEVICEK955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK955011CANDELA HCS 2000 URETHERAL WARMER CATHETERK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEM

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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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