510(k) K160392 ยท GEX Powered Laser Surgical Instrument
Novilase Laser Therapy System, Model LTS-2
| Applicant | Novian Health, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Feb 26, 2016 |
| Received | Feb 11, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160392
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.