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510(k) K171354

MR4 Laser by Multi Radiance Medical — Product Code NHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2018
Date Received
May 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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.

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  • K221987 — Erchonia GVL (September 1, 2022)
  • K203337 — PainTB, PainTJ (February 11, 2022)
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  • K211186 — Erchonia XLR8 (October 22, 2021)