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FDA 510(k)

MDL-2000 LASERTRIPTER

K-Number: K901723 · 1990-07-13

ApplicantCandela Laser Corp.
Decision Date1990-07-13
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MDL-2000 LASERTRIPTER 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 1990-07-13 under 510(k) number K901723. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDL-2000 LASERTRIPTER?

MDL-2000 LASERTRIPTER is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is Candela Laser Corp.. The 510(k) number is K901723.

When did MDL-2000 LASERTRIPTER receive FDA 510(k) clearance?

MDL-2000 LASERTRIPTER received FDA 510(k) clearance on 1990-07-13, under 510(k) number K901723.

Who is the listed applicant for MDL-2000 LASERTRIPTER?

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 MDL-2000 LASERTRIPTER?

The FDA product code for MDL-2000 LASERTRIPTER is LNK.

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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: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYSurgilase, Inc.

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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