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, Erchonia Medical, Inc. and Stargate International, Inc..
54
Total
54
Cleared
185d
Avg days
2002
Since
54 devices
Cleared
Feb 10, 2003
THOR DDII 830CL3 LASER SYSTEM
Thor Intl.
Physical Medicine
19d
Cleared
Jan 28, 2003
TRILUMINA THERAPEUTIC LASER SYSTEM
Texas Applied Biomedical Services
Physical Medicine
63d
Cleared
Sep 10, 2002
MEDX LCS LASER SERIES
Medx Electronics, Inc.
Physical Medicine
84d
Cleared
Jul 29, 2002
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
Acculaser, Inc.
Physical Medicine
151d
Cleared
Feb 06, 2002
MICROLIGHT 830 LASER SYSTEM
Microlight Corporation of America
Physical Medicine
384d
Cleared
Jan 17, 2002
ERCHONIA PL2000
Tuco Innovations, Inc.
Physical Medicine
161d