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FDA 510(k)

FIBERLAS 100 MEDICAL SYSTEM

K-Number: K833499 · 1984-04-02

ApplicantFiberlase U.S.A.
Decision Date1984-04-02
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FIBERLAS 100 MEDICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fiberlase U.S.A.. It received FDA 510(k) clearance on 1984-04-02 under 510(k) number K833499. 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 FIBERLAS 100 MEDICAL SYSTEM?

FIBERLAS 100 MEDICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1984-04-02. The listed applicant is Fiberlase U.S.A.. The 510(k) number is K833499.

When did FIBERLAS 100 MEDICAL SYSTEM receive FDA 510(k) clearance?

FIBERLAS 100 MEDICAL SYSTEM received FDA 510(k) clearance on 1984-04-02, under 510(k) number K833499.

Who is the listed applicant for FIBERLAS 100 MEDICAL SYSTEM?

The FDA 510(k) record lists Fiberlase U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBERLAS 100 MEDICAL SYSTEM?

The FDA product code for FIBERLAS 100 MEDICAL SYSTEM is LNK.

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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.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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