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, Dmc Importacao E Exportacao DE Equipamentos Ltda and Wuhan Guangdun Technology Co.,Ltd...
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)
About Product Code NHN - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code NHN since 2002, with 53 receiving FDA clearance (average review time: 185 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NHN have taken an average of 283 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 →