NHN · Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Physical Medicine · 21 CFR 890.5500 · Class 2
Overview
| Product Code | NHN |
|---|---|
| Device Name | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Classification Rationale
Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251903 | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | Feb 19, 2026 | SESE |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | Dec 12, 2025 | SESE |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | Jan 24, 2025 | SESE |
| K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | Dec 19, 2024 | SESE |
| K231409 | Erchonia FX-405 | Erchonia Corporation | Aug 11, 2023 | SESE |
| K212189 | FibroLux | Multi Radiance Medical | Sep 2, 2022 | SESE |
| K221987 | Erchonia GVL | Erchonia Corporation | Sep 1, 2022 | SESE |
| K203337 | PainTB, PainTJ | Ptech Co., Ltd. | Feb 11, 2022 | SESE |
| K212595 | Erchonia FX-405 | Erchonia Corporation | Nov 12, 2021 | SESE |
| K211186 | Erchonia XLR8 | Erchonia Corporation | Oct 22, 2021 | SESE |
| K191257 | Erchonia EVRL | Erchonia Corporation | Aug 8, 2019 | SESE |
| K190572 | Erchonia FX-635 | Erchonia Corporation | Jun 1, 2019 | SESE |
| K180197 | Erchonia FX-635 | Erchonia Corporation | May 21, 2018 | SESE |
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | May 11, 2018 | SESE |
| K171354 | MR4 Laser | Multi Radiance Medical | Jan 13, 2018 | SESE |
| K162022 | Collagentex Rx-1 | Tanses Technologies, Inc. | Dec 22, 2016 | SESE |
| K152196 | Erchonia EVRL | Erchonia Corporation | Feb 18, 2016 | SESE |
| K153052 | Erchonia PL Touch | Erchonia Corporation | Jan 4, 2016 | SESE |
| K151816 | TLC-2000 Therapeutic Medical Laser System | Theralase, Inc. | Nov 19, 2015 | SESE |
| K132940 | ERCHONIA ALLAY | Erchonia Medical, Inc. | Apr 14, 2014 | SESE |
Top Applicants
- Erchonia Corporation — 12 clearances
- Erchonia Medical, Inc. — 5 clearances
- Stargate International, Inc. — 3 clearances
- Acculaser, Inc. — 2 clearances
- Axiom Usa., Inc. — 2 clearances
