Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) → NHN — Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy # 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_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN ## 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](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K251903.md) | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | Feb 19, 2026 | SESE | | [K252273](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K252273.md) | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | Dec 12, 2025 | SESE | | [K241057](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K241057.md) | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | Jan 24, 2025 | SESE | | [K232813](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K232813.md) | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | Dec 19, 2024 | SESE | | [K231409](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K231409.md) | Erchonia FX-405 | Erchonia Corporation | Aug 11, 2023 | SESE | | [K212189](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K212189.md) | FibroLux | Multi Radiance Medical | Sep 2, 2022 | SESE | | [K221987](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K221987.md) | Erchonia GVL | Erchonia Corporation | Sep 1, 2022 | SESE | | [K203337](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K203337.md) | PainTB, PainTJ | Ptech Co., Ltd. | Feb 11, 2022 | SESE | | [K212595](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K212595.md) | Erchonia FX-405 | Erchonia Corporation | Nov 12, 2021 | SESE | | [K211186](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K211186.md) | Erchonia XLR8 | Erchonia Corporation | Oct 22, 2021 | SESE | | [K191257](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K191257.md) | Erchonia EVRL | Erchonia Corporation | Aug 8, 2019 | SESE | | [K190572](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K190572.md) | Erchonia FX-635 | Erchonia Corporation | Jun 1, 2019 | SESE | | [K180197](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K180197.md) | Erchonia FX-635 | Erchonia Corporation | May 21, 2018 | SESE | | [K180585](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K180585.md) | Collagentex Rx-6 | Tanses Technologies, Inc. | May 11, 2018 | SESE | | [K171354](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K171354.md) | MR4 Laser | Multi Radiance Medical | Jan 13, 2018 | SESE | | [K162022](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K162022.md) | Collagentex Rx-1 | Tanses Technologies, Inc. | Dec 22, 2016 | SESE | | [K152196](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K152196.md) | Erchonia EVRL | Erchonia Corporation | Feb 18, 2016 | SESE | | [K153052](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K153052.md) | Erchonia PL Touch | Erchonia Corporation | Jan 4, 2016 | SESE | | [K151816](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K151816.md) | TLC-2000 Therapeutic Medical Laser System | Theralase, Inc. | Nov 19, 2015 | SESE | | [K132940](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K132940.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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