NHN · Class II · 21 CFR 890.5500

FDA Product Code NHN: Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

Non-thermal laser therapy uses light energy without generating destructive heat, expanding its safe applications in rehabilitation. FDA product code NHN covers powered non-thermal light-based laser instruments.

These devices deliver low-level laser or light energy to tissue to modulate cellular activity, reduce inflammation, and promote healing — without thermal damage. They are used in pain management, wound healing, and musculoskeletal rehabilitation.

NHN devices are Class II medical devices, regulated under 21 CFR 890.5500 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include Erchonia Corporation, Multi Radiance Medical and Tanses Technologies, Inc..

54
Total
54
Cleared
185d
Avg days
2002
Since
Growing category - 5 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 257d recently vs 178d historically

FDA 510(k) Cleared Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy Devices (Product Code NHN)

54 devices
1–24 of 54
Cleared May 19, 2026
MR5 Activ Pro
K254024
Multi Radiance Medical, Inc.
Physical Medicine · 154d
Cleared Feb 19, 2026
Erchonia DPN Laser (Model# EVRL)
K251903
Erchonia Corporation
Physical Medicine · 244d
Cleared Dec 12, 2025
Therapy US
K252273
Dmc Importa??o E Exporta??o DE Equipamentos Ltda
Physical Medicine · 143d
Cleared Jan 24, 2025
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
K241057
Wuhan Guangdun Technology Co.,Ltd..
Physical Medicine · 281d
Cleared Dec 19, 2024
Therapy EC, Therapy XT
K232813
Dmc Importacao E Exportacao DE Equipamentos Ltda
Physical Medicine · 463d
Cleared Aug 11, 2023
Erchonia FX-405
K231409
Erchonia Corporation
Physical Medicine · 88d
Cleared Sep 02, 2022
FibroLux
K212189
Multi Radiance Medical
Physical Medicine · 416d
Cleared Sep 01, 2022
Erchonia GVL
K221987
Erchonia Corporation
General & Plastic Surgery · 57d
Cleared Feb 11, 2022
PainTB, PainTJ
K203337
Ptech Co., Ltd.
Physical Medicine · 456d
Cleared Nov 12, 2021
Erchonia FX-405
K212595
Erchonia Corporation
Physical Medicine · 88d
Cleared Oct 22, 2021
Erchonia XLR8
K211186
Erchonia Corporation
Physical Medicine · 185d
Cleared Aug 08, 2019
Erchonia EVRL
K191257
Erchonia Corporation
General & Plastic Surgery · 90d
Cleared Jun 01, 2019
Erchonia FX-635
K190572
Erchonia Corporation
Physical Medicine · 87d
Cleared May 21, 2018
Erchonia FX-635
K180197
Erchonia Corporation
Physical Medicine · 117d
Cleared May 11, 2018
Collagentex Rx-6
K180585
Tanses Technologies, Inc.
Physical Medicine · 67d
Cleared Jan 13, 2018
MR4 Laser
K171354
Multi Radiance Medical
Physical Medicine · 249d
Cleared Feb 18, 2016
Erchonia EVRL
K152196
Erchonia Corporation
Physical Medicine · 197d
Cleared Jan 04, 2016
Erchonia PL Touch
K153052
Erchonia Corporation
Physical Medicine · 76d

About Product Code NHN - Regulatory Context

510(k) Submission Activity

54 total 510(k) submissions under product code NHN since 2002, with 54 receiving FDA clearance (average review time: 185 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NHN Product Code

Recent submissions under NHN have taken an average of 257 days to reach a decision - up from 178 days historically. Manufacturers should account for longer review timelines in current project planning.

NHN devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →