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)

MEDX LCS LASER SERIES

K-Number: K021985 · 2002-09-10

ApplicantMedx Electronics, Inc.
Decision Date2002-09-10
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEDX LCS LASER SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Medx Electronics, Inc.. It received FDA 510(k) clearance on 2002-09-10 under 510(k) number K021985. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDX LCS LASER SERIES?

MEDX LCS LASER SERIES is a medical device that received FDA 510(k) clearance on 2002-09-10. The listed applicant is Medx Electronics, Inc.. The 510(k) number is K021985.

When did MEDX LCS LASER SERIES receive FDA 510(k) clearance?

MEDX LCS LASER SERIES received FDA 510(k) clearance on 2002-09-10, under 510(k) number K021985.

Who is the listed applicant for MEDX LCS LASER SERIES?

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

What is the FDA product code for MEDX LCS LASER SERIES?

The FDA product code for MEDX LCS LASER SERIES is NHN.

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 Medx Electronics, 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.

K082707MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASERK050022MEDX HOMEK032231MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASERK024310NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORYK020017MEDX 1000 SERIES

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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.

↑