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)

EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001

K-Number: K051631 · 2005-07-27

ApplicantStargate International, Inc.
Decision Date2005-07-27
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 is the device name listed in this FDA 510(k) record. The listed applicant is Stargate International, Inc.. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K051631. 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 EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001?

EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Stargate International, Inc.. The 510(k) number is K051631.

When did EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 receive FDA 510(k) clearance?

EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051631.

Who is the listed applicant for EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001?

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

What is the FDA product code for EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001?

The FDA product code for EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 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 Stargate International, 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.

K041530EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001K032816QUANTUM LIGHT THERAPY SYSTEM

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.

↑