Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K140732
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS · Candela Corp. · decided 2014-11-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| MGL 6/8/10MM RGD Fiber | 7122-00-3833 | Candela Corporation | GEX | 00817495021928 |
| GentleLASE | 9914-12-0888 | Candela Corporation | GEX | 00817495020716 |
| GentleLASE Pro | 9914-00-9015 | Candela Corporation | GEX | 00817495020075 |
| Specialty Delivery System Kit , no 5mm SA | 7123-00-0307 | Candela Corporation | GEX | 00817495022710 |
| GentleLASE | 9914-12-0898 | Candela Corporation | GEX | 00817495020754 |
| Glase Pro U Laser System | 9914-CH-9030 | Candela Corporation | GEX | 00817495024646 |
| FSE MGL 12/15/18 RGD Delivery System | 7122-57-3797 | Candela Corporation | GEX | 00817495022550 |
| GentleYAG 1.5/3MM Delivery System W/O DCD | 7122-00-3558 | Candela Corporation | GEX | 00817495021904 |
| GentleLASE Pro-U | 9914-15-9030 | Candela Corporation | GEX | 00817495020938 |
| Open | Open | Candela Corporation | GEX | 00817495021942 |
| Specialty Delivery System Assembly | 7122-00-9616 | Candela Corporation | GEX | 00817495021171 |
| GentleLase 6/8/10MM RGD Delivery System W/O Fiber | 7122-00-8506 | Candela Corporation | GEX | 00817495022383 |
| Brazilian In Metro TUV Conversion Kit | 7122-00-9663 | Candela Corporation | GEX | 00817495021218 |
| GentleLASE Pro-U | 9914-12-9040 | Candela Corporation | GEX | 00817495020983 |
| GentleLASE Pro | 9914-12-9015 | Candela Corporation | GEX | 00817495020877 |
| GentleLase LE Delivery System W/O | 0800-00-0970 | Candela Corporation | GEX | 00817495022031 |
| FSE PF1 6-18MM Delivery System W/DCD Assembly | 7122-57-3956 | Candela Corporation | GEX | 00817495022543 |
| GL 15MM Fiber Assembly | 7121-00-7240 | Candela Corporation | GEX | 00817495022475 |
| GentleLase LE 12MM Delivery System W/DCD | 0800-00-1072 | Candela Corporation | GEX | 00817495022062 |
| GentleLASE Limited Edition | 9914-00-0911 | Candela Corporation | GEX | 00817495020785 |
| GentleMax | 9914-00-0400 | Candela Corporation | GEX | 00817495020181 |
| GentleLASE Pro-U | 9914-00-9030 | Candela Corporation | GEX | 00817495020082 |
| GentleLASE | 9914-00-0880 | Candela Corporation | GEX | 00817495020099 |
| Fiber Cable Assembly | 7121-00-2141 | Candela Corporation | GEX | 00817495022468 |
| GentleLASE | 9914-00-2130 | Candela Corporation | GEX | 00817495020228 |