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Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Regulation 890.5500

3510(k)s in 12 months (54 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in NHN

Company510(k)sRecalls
Erchonia Corporation120
Theralase, Inc.27
Erchonia Medical, Inc.50
Multi Radiance Medical30
Stargate International, Inc.30
Acculaser, Inc.20
Axiom Usa., Inc.20
Medx Electronics, Inc.20
Tanses Technologies, Inc.20
2035, Inc.10
DateFirm and productCodeLinked 510(k)
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated		 NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Terminated		 NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated		 NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Terminated		 NHNK151816
Dec 5, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Terminated		 NHNK151816
Dec 5, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Terminated		 NHNK151816
Sep 26, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated		 NHNK151816

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