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)

TECHNOMED PULSOLITH 4000 LASER SYSTEM

K-Number: K925395 · 1993-05-21

ApplicantTeknomed, Inc.
Decision Date1993-05-21
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECHNOMED PULSOLITH 4000 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teknomed, Inc.. It received FDA 510(k) clearance on 1993-05-21 under 510(k) number K925395. 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 TECHNOMED PULSOLITH 4000 LASER SYSTEM?

TECHNOMED PULSOLITH 4000 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Teknomed, Inc.. The 510(k) number is K925395.

When did TECHNOMED PULSOLITH 4000 LASER SYSTEM receive FDA 510(k) clearance?

TECHNOMED PULSOLITH 4000 LASER SYSTEM received FDA 510(k) clearance on 1993-05-21, under 510(k) number K925395.

Who is the listed applicant for TECHNOMED PULSOLITH 4000 LASER SYSTEM?

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

What is the FDA product code for TECHNOMED PULSOLITH 4000 LASER SYSTEM?

The FDA product code for TECHNOMED PULSOLITH 4000 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.

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 Teknomed, Inc. 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.

K920708MULTILASE 2500 AK913917MULTILASE 2100 C, 2100 DK913290MULTILASE 2100 AK895178TECHNOMED PULSOLITH LASER SYSTEMK890436TECHNOMED PULSOLITH LASER SYSTEMK790132TECNOTOMO

View all 7 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.

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.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.

↑