Panels › Physical Medicine › Product code NHN · Class 2
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Regulation 890.5500
3510(k)s in 12 months (54 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in NHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Erchonia Corporation | 12 | 0 |
| Theralase, Inc. | 2 | 7 |
| Erchonia Medical, Inc. | 5 | 0 |
| Multi Radiance Medical | 3 | 0 |
| Stargate International, Inc. | 3 | 0 |
| Acculaser, Inc. | 2 | 0 |
| Axiom Usa., Inc. | 2 | 0 |
| Medx Electronics, Inc. | 2 | 0 |
| Tanses Technologies, Inc. | 2 | 0 |
| 2035, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2002 | K021985 | MEDX LCS LASER SERIES Medx Electronics, Inc., CA | NHN |
| Jul 29, 2002 | K020657 | ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE Acculaser, Inc. | NHN |
| Feb 6, 2002 | K010175 | MICROLIGHT 830 LASER SYSTEM Microlight Corporation of America | NHN |
| Jan 17, 2002 | K012580 | ERCHONIA PL2000 Tuco Innovations, Inc. | NHN |
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