The following data is part of a premarket notification filed by Premier Dynamics, Inc. with the FDA for Spectra Therapy System A1000 Laser Device.
| Device ID | K080689 |
| 510k Number | K080689 |
| Device Name: | SPECTRA THERAPY SYSTEM A1000 LASER DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | PREMIER DYNAMICS, INC. 3863 ROCHESTER ROAD Troy, MI 48083 |
| Contact | John J Stephan |
| Correspondent | John J Stephan PREMIER DYNAMICS, INC. 3863 ROCHESTER ROAD Troy, MI 48083 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-07-09 |
| Summary: | summary |