Therapy EC, Therapy XT
FDA 510(k) K232813 · Dmc Importacao E Exportacao DE Equipamentos Ltda
Submission
- Device name
- Therapy EC, Therapy XT
- Applicant
- Dmc Importacao E Exportacao DE Equipamentos Ltda
Sao Carlos, BR - Received
- September 13, 2023
- Decision date
- December 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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…
Other 510(k)s with product code NHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254024 | MR5 Activ ProNHN · Traditional | Multi Radiance Medical, Inc. | 05/19/2026SE |
| K251903 | Erchonia DPN Laser (Model# EVRL)NHN · Traditional | Erchonia Corporation | 02/19/2026SE |
| K252273 | Therapy USNHN · Traditional | Dmc Importação E Exportação DE Equipamentos Ltda | 12/12/2025SE |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)NHN · Traditional | Wuhan Guangdun Technology Co.,Ltd.. | 01/24/2025SE |
| K231409 | Erchonia FX-405NHN · Traditional | Erchonia Corporation | 08/11/2023SE |
| K212189 | FibroLuxNHN · Traditional | Multi Radiance Medical | 09/02/2022SE |
| K221987 | Erchonia GVLNHN · Traditional | Erchonia Corporation | 09/01/2022SE |
| K203337 | PainTB, PainTJNHN · Traditional | Ptech Co., Ltd. | 02/11/2022SE |
| K212595 | Erchonia FX-405NHN · Traditional | Erchonia Corporation | 11/12/2021SE |
| K211186 | Erchonia XLR8NHN · Traditional | Erchonia Corporation | 10/22/2021SE |
Questions and answers
When was Therapy EC, Therapy XT cleared by the FDA?
Therapy EC, Therapy XT (K232813) received a 510(k) decision of Substantially Equivalent on December 19, 2024, 463 days after the submission was received.
What is the product code of K232813?
The FDA product code is NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a Class II (moderate risk) device regulated under 21 CFR 890.5500.