Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201111
GentleMax Pro Plus · Candela Corporation · decided 2020-05-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DCD HAND PIECE, LARGE SPOT, GMPP | 7123-CE-0631 | Candela Corporation | GEX | 00817495023151 |
| FIBER, STANDARD, HC, GMPP | 7123-CE-0658 | Candela Corporation | GEX | 00817495025186 |
| GMPP Modified LSDS (HRDS) Options Kit for ACC | FIN101959 | Candela Corporation | GEX | 00817495023915 |
| Refurbished GentleMax Pro Plus | 9914-58-9036 | Candela Corporation | GEX | 00817495024080 |
| ACC HAND PIECE, LARGE SPOT, GMPP | 7123-CE-0628 | Candela Corporation | GEX | 00817495023137 |
| GentleMax Pro Plus | 7123-00-0650 | Candela Corporation | GEX | 00817495023052 |
| GMPP DCD Small Spot Option Kit, w/Fiber Assembly | 7123-CE-0650 | Candela Corporation | GEX | 00817495023205 |
| ASSY, ACC HAND PIECE, LARGE SPOT, GMPP | 7123-CE-0628 | Candela Corporation | GEX | 00817495023977 |
| GentleMax Pro Plus | 9914-15-9036 | Candela Corporation | GEX | 00817495022970 |
| GentleMAX PRO PLUS Laser System | 9914-CE-9036 | Candela Corporation | GEX | 00817495023120 |
| DCD HAND PIECE, SMALL SPOT, GMPP | 7123-CE-0633 | Candela Corporation | GEX | 00817495023175 |
| MSDS DCD Option Kit GMPP | FIN103337 | Candela Corporation | GEX | 00817495024011 |
| ASSY, ACC HAND PIECE, LARGE SPOT, GMPP | 7123-00-0628 | Candela Corporation | GEX | 00817495022987 |
| GMPP Modified LSDS (HRDS) Options Kit for DCD | FIN101958 | Candela Corporation | GEX | 00817495023854 |
| GMAX Pro Plus Laser System | 9914-CH-9036 | Candela Corporation | GEX | 00817495023571 |
| GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly | 7123-CE-0652 | Candela Corporation | GEX | 00817495024035 |
| FIBER, STANDARD, HC, GMPP | 7123-CE-0658 | Candela Corporation | GEX | 00817495025155 |
| Modified LSDS Fiber Assembly, 12-26 mm | SBA100775 | Candela Corporation | GEX | 00817495023946 |
| GentleMAX PRO PLUS Laser System | 9914-00-9036 | Candela Corporation | GEX | 00817495024127 |
| GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly | 7123-CE-0653 | Candela Corporation | GEX | 00817495024042 |
| ACC HAND PIECE, MEDIUM SPOT, GMPP | 7123-CE-0629 | Candela Corporation | GEX | 00817495023144 |
| GMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly | 7123-CE-0651 | Candela Corporation | GEX | 00817495023212 |
| GMAX Pro Plus Laser System | 9914-CH-9036 | Candela Corporation | GEX | 00817495024660 |
| GentleMax Pro Plus | 7123-00-0651 | Candela Corporation | GEX | 00817495023069 |
| GentleMax Pro Plus | 7123-00-0633 | Candela Corporation | GEX | 00817495023021 |