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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Definition A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.
Product CodeNHN
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
ERCHONIA CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MULTI RADIANCE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fatigue 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Dizziness 1 1
Neck Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Theralase Inc. III Feb-24-2020
2 Theralase Inc. III Feb-13-2020
3 Theralase Inc. III Feb-13-2020
4 Theralase Inc. III Feb-13-2020
5 Theralase Inc. III Feb-13-2020
6 Theralase Inc. III Dec-05-2019
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