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FDA 510(k)

EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001

K-Number: K041530 · 2004-10-14

ApplicantStargate International, Inc.
Decision Date2004-10-14
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 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 2004-10-14 under 510(k) number K041530. 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 LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001?

EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Stargate International, Inc.. The 510(k) number is K041530.

When did EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 receive FDA 510(k) clearance?

EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 received FDA 510(k) clearance on 2004-10-14, under 510(k) number K041530.

Who is the listed applicant for EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001?

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 LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001?

The FDA product code for EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 is NHN.

Related Clinical Trials

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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.

K051631EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001K032816QUANTUM 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

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

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