510(k) K123435 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
IPL THERAPY SYSTEM
| Applicant | Beijing Sincoheren S&T Development Co, Ltd., Guangzhou, Guangdong, CN |
| Decision | Substantially Equivalent, Feb 11, 2013 |
| Received | Nov 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123435
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.