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FDA 510(k)

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM

K-Number: K850509 · 1985-04-08

ApplicantLaser Media
Decision Date1985-04-08
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laser Media. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850509. 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 ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM?

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Laser Media. The 510(k) number is K850509.

When did ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM receive FDA 510(k) clearance?

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850509.

Who is the listed applicant for ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM?

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

What is the FDA product code for ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM?

The FDA product code for ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM is LNK.

Related Clinical Trials

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.

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Other records listing Laser Media 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.

K872352FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIAK872351FIBERLASE II ND:YAG LASER FOR PULMONARY USEK872350FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USEK872031UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEMK863428SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAGK863583CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER

View all 12 devices →

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.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.

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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