Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM

K-Number: K872031 · 1987-08-04

ApplicantLaser Media
Decision Date1987-08-04
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY 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 1987-08-04 under 510(k) number K872031. 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 UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM?

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1987-08-04. The listed applicant is Laser Media. The 510(k) number is K872031.

When did UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM receive FDA 510(k) clearance?

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM received FDA 510(k) clearance on 1987-08-04, under 510(k) number K872031.

Who is the listed applicant for UNI-FIBER NON-REPAIRABLE FIBER DELIVERY 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 UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM?

The FDA product code for UNI-FIBER NON-REPAIRABLE FIBER DELIVERY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 USEK863428SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAGK863583CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASERK862444FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA

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.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

View on FDA Database →

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

↑