510(k) K080689 ยท ILY Lamp, Infrared, Therapeutic Heating
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
| Applicant | Premier Dynamics, Inc., Troy MI, US |
| Decision | Substantially Equivalent, Jul 9, 2008 |
| Received | Mar 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080689
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.