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
Apr 03, 2009
LIGHTSTREAM LOW LEVEL LASER
Solica Corporation
Physical Medicine
344d
Cleared
Jan 30, 2009
QLASER SYSTEM
2035, Inc.
Physical Medicine
340d
Cleared
Nov 13, 2008
LEP2000 THERAPY SYSTEM
International Medical Instruments, Inc.
Physical Medicine
321d
Cleared
Apr 24, 2008
ERCHONIA EML LASER
Erchonia Medical, Inc.
Physical Medicine
260d
Cleared
Apr 02, 2008
LD-I 75 AND LD-I 200
Meditech International, Inc.
Physical Medicine
205d
Cleared
Jan 29, 2007
LUMINEX LL LASER SYSTEM
Medical Laser Systems, Inc.
Physical Medicine
61d
Cleared
Mar 15, 2006
ELITE ELECTROMED L.I.T.E. 4/1
Elite Electromedical
Physical Medicine
89d
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
Jan 21, 2005
LAPEX 2000
Meridian Co., Ltd.
Physical Medicine
394d
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
Cleared
Mar 26, 2004
QUANTUM LIGHT THERAPY SYSTEM
Stargate International, Inc.
Physical Medicine
199d
Cleared
Mar 19, 2004
ACCULASER PRO4
Acculaser, Inc.
Physical Medicine
553d
Cleared
Feb 04, 2004
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
Bioptron AG
Physical Medicine
198d
Cleared
Nov 25, 2003
AXIOM BIOLASER LLLT SERIES-3
Axiom Usa., Inc.
Physical Medicine
60d
Cleared
Sep 16, 2003
DIOBEAM 830
Soft-Core Texas, Inc.
Physical Medicine
126d
Cleared
Sep 09, 2003
AXIOM BIOLASER LLLT SERIES-1
Axiom Usa., Inc.
Physical Medicine
194d
Cleared
Jul 17, 2003
POWER LASER 90
Andi Electromedical Aps
Physical Medicine
134d
Cleared
Mar 24, 2003
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
Medx Electronics, Inc.
Physical Medicine
90d