NHN · Class II · 21 CFR 890.5500

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
25–48 of 54
Cleared Jun 08, 2010
THL1 LASER
K100509
Erchonia Corporation
Physical Medicine · 106d
Cleared Apr 03, 2009
LIGHTSTREAM LOW LEVEL LASER
K081166
Solica Corporation
Physical Medicine · 344d
Cleared Jan 30, 2009
QLASER SYSTEM
K080513
2035, Inc.
Physical Medicine · 340d
Cleared Nov 13, 2008
LEP2000 THERAPY SYSTEM
K073689
International Medical Instruments, Inc.
Physical Medicine · 321d
Cleared Apr 24, 2008
ERCHONIA EML LASER
K072206
Erchonia Medical, Inc.
Physical Medicine · 260d
Cleared Apr 02, 2008
LD-I 75 AND LD-I 200
K072551
Meditech International, Inc.
Physical Medicine · 205d
Cleared Jan 29, 2007
LUMINEX LL LASER SYSTEM
K063574
Medical Laser Systems, Inc.
Physical Medicine · 61d
Cleared Mar 15, 2006
ELITE ELECTROMED L.I.T.E. 4/1
K053507
Elite Electromedical
Physical Medicine · 89d
Cleared Feb 03, 2006
GRT LITE, MODEL 8-A
K050668
Grt Solutions, Inc.
Physical Medicine · 325d
Cleared Jul 27, 2005
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
K051631
Stargate International, Inc.
Physical Medicine · 37d
Cleared Jul 11, 2005
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
K050342
Theralase, Inc.
Physical Medicine · 150d
Cleared Jul 01, 2005
OMEGA EXCEL/XP LASER SYSTEM
K043353
Advanced Medical Technologies, Inc.
Physical Medicine · 207d
Cleared Mar 03, 2005
LAZRPULSR 4X
K041565
Led Healing Light, LLC
Physical Medicine · 266d
Cleared Jan 21, 2005
LAPEX 2000
K034009
Meridian Co., Ltd.
Physical Medicine · 394d
Cleared Oct 14, 2004
EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
K041530
Stargate International, Inc.
Physical Medicine · 128d
Cleared Sep 30, 2004
ERCHONIA EML LASER
K041139
Erchonia Medical, Inc.
Physical Medicine · 153d
Cleared Mar 26, 2004
QUANTUM LIGHT THERAPY SYSTEM
K032816
Stargate International, Inc.
Physical Medicine · 199d
Cleared Mar 19, 2004
ACCULASER PRO4
K023060
Acculaser, Inc.
Physical Medicine · 553d
Cleared Feb 04, 2004
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
K032216
Bioptron AG
Physical Medicine · 198d
Cleared Nov 25, 2003
AXIOM BIOLASER LLLT SERIES-3
K033015
Axiom Usa., Inc.
Physical Medicine · 60d
Cleared Sep 16, 2003
DIOBEAM 830
K031499
Soft-Core Texas, Inc.
Physical Medicine · 126d
Cleared Sep 09, 2003
AXIOM BIOLASER LLLT SERIES-1
K030622
Axiom Usa., Inc.
Physical Medicine · 194d
Cleared Jul 17, 2003
POWER LASER 90
K030692
Andi Electromedical Aps
Physical Medicine · 134d
Cleared Mar 24, 2003
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
K024310
Medx Electronics, Inc.
Physical Medicine · 90d