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..
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
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 →