510(k) K013825 ยท GEX Powered Laser Surgical Instrument
CANDELA SMOOTHBEAM LASER SYSTEM
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Feb 15, 2002 |
| Received | Nov 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 1, 2004 | Candela Laser Corporation Candela Smoothbeam Laser System
Model Numbers: 9914-00-0820
9914-06-0820
9914-07-0820
9914-08-0820
Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.