The following data is part of a premarket notification filed by Andi Electromedical Aps with the FDA for Power Laser 90.
| Device ID | K030692 |
| 510k Number | K030692 |
| Device Name: | POWER LASER 90 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | ANDI ELECTROMEDICAL APS 12415 OLD MERIDIAN ST. Carmel, IN 46032 |
| Contact | Jeff Worrell |
| Correspondent | Jeff Worrell ANDI ELECTROMEDICAL APS 12415 OLD MERIDIAN ST. Carmel, IN 46032 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-05 |
| Decision Date | 2003-07-17 |
| Summary: | summary |