510(k) K232813

Therapy EC, Therapy XT by Dmc Importacao E Exportacao DE Equipamentos Ltda — Product Code NHN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 19, 2024
Date Received: September 13, 2023
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.

Other clearances for product code NHN

K251903 — Erchonia DPN Laser (Model# EVRL) (February 19, 2026)
K252273 — Therapy US (December 12, 2025)
K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (January 24, 2025)
K231409 — Erchonia FX-405 (August 11, 2023)
K212189 — FibroLux (September 2, 2022)
K221987 — Erchonia GVL (September 1, 2022)
K203337 — PainTB, PainTJ (February 11, 2022)
K212595 — Erchonia FX-405 (November 12, 2021)
K211186 — Erchonia XLR8 (October 22, 2021)
K191257 — Erchonia EVRL (August 8, 2019)