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
Jun 08, 2010
THL1 LASER
Erchonia Corporation
Physical Medicine
106d
Cleared
Feb 03, 2006
GRT LITE, MODEL 8-A
Grt Solutions, Inc.
Physical Medicine
325d
Cleared
Jul 27, 2005
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
Stargate International, Inc.
Physical Medicine
37d
Cleared
Jul 11, 2005
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
Theralase, Inc.
Physical Medicine
150d
Cleared
Jul 01, 2005
OMEGA EXCEL/XP LASER SYSTEM
Advanced Medical Technologies, Inc.
Physical Medicine
207d
Cleared
Mar 03, 2005
LAZRPULSR 4X
Led Healing Light, LLC
Physical Medicine
266d
Cleared
Oct 14, 2004
EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
Stargate International, Inc.
Physical Medicine
128d
Cleared
Sep 30, 2004
ERCHONIA EML LASER
Erchonia Medical, Inc.
Physical Medicine
153d