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)

ND-YAG LASER FOR UROLOGICAL SURGERY

K-Number: K843293 · 1984-10-02

ApplicantEndo Lase, Inc.
Decision Date1984-10-02
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ND-YAG LASER FOR UROLOGICAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Endo Lase, Inc.. It received FDA 510(k) clearance on 1984-10-02 under 510(k) number K843293. 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 LASER FOR UROLOGICAL SURGERY?

ND-YAG LASER FOR UROLOGICAL SURGERY is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Endo Lase, Inc.. The 510(k) number is K843293.

When did ND-YAG LASER FOR UROLOGICAL SURGERY receive FDA 510(k) clearance?

ND-YAG LASER FOR UROLOGICAL SURGERY received FDA 510(k) clearance on 1984-10-02, under 510(k) number K843293.

Who is the listed applicant for ND-YAG LASER FOR UROLOGICAL SURGERY?

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

What is the FDA product code for ND-YAG LASER FOR UROLOGICAL SURGERY?

The FDA product code for ND-YAG LASER FOR UROLOGICAL SURGERY 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 Endo Lase, 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.

K853900ENDO-LASE CD40 FOR NEUROSURGERYK853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERYK855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEMK853903ENDO-LASE CD40 CO2 FOR GYNECOLOGYK853876ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGYK853901ENDO-LASE CD 40 FOR DERMATOLOGY

View all 24 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.

↑