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FDA 510(k)

THOR DDII 830CL3 LASER SYSTEM

K-Number: K030226 · 2003-02-10

ApplicantThor Intl.
Decision Date2003-02-10
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THOR DDII 830CL3 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thor Intl.. It received FDA 510(k) clearance on 2003-02-10 under 510(k) number K030226. 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 THOR DDII 830CL3 LASER SYSTEM?

THOR DDII 830CL3 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-10. The listed applicant is Thor Intl.. The 510(k) number is K030226.

When did THOR DDII 830CL3 LASER SYSTEM receive FDA 510(k) clearance?

THOR DDII 830CL3 LASER SYSTEM received FDA 510(k) clearance on 2003-02-10, under 510(k) number K030226.

Who is the listed applicant for THOR DDII 830CL3 LASER SYSTEM?

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

What is the FDA product code for THOR DDII 830CL3 LASER SYSTEM?

The FDA product code for THOR DDII 830CL3 LASER SYSTEM 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.

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Other records listing Thor Intl. 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.

K033923TH0R DDII IR LAMP 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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