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FDA 510(k)

MDL-1 LASERTRIPTER(TM)

K-Number: K885255 · 1989-06-01

ApplicantCandela Laser Corp.
Decision Date1989-06-01
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MDL-1 LASERTRIPTER(TM) 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 1989-06-01 under 510(k) number K885255. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDL-1 LASERTRIPTER(TM)?

MDL-1 LASERTRIPTER(TM) is a medical device that received FDA 510(k) clearance on 1989-06-01. The listed applicant is Candela Laser Corp.. The 510(k) number is K885255.

When did MDL-1 LASERTRIPTER(TM) receive FDA 510(k) clearance?

MDL-1 LASERTRIPTER(TM) received FDA 510(k) clearance on 1989-06-01, under 510(k) number K885255.

Who is the listed applicant for MDL-1 LASERTRIPTER(TM)?

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-1 LASERTRIPTER(TM)?

The FDA product code for MDL-1 LASERTRIPTER(TM) is FFK.

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Other records listing Candela Laser Corp. as applicant

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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: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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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