Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181523
Syneron CO2RE System · Syneron-Candela Corp · decided 2018-07-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Internal, CO2RE Intima | KT76614US | SYNERON MEDICAL LTD | GEX | 17290109950379 |
| Standard 2 Hand-piece packing Assy, CO2RE | AS87532 | Candela Corporation | GEX | 00817495024363 |
| Regular Internal Handpiece Sterile Single-Use, CO2RE Intima | AS95191 | Candela Corporation | GEX | 00817495025056 |
| 5-Pk, external hygienic, CO2RE Intima | KT76685 | Candela Corporation | GEX | 00817495024400 |
| CO2RE system | FG70412 | Candela Corporation | GEX | 00817495024264 |
| CO2RE System, Packaged (Japan) | FG70412JP | Candela Corporation | GEX | 00817495024271 |
| Standard Hand-piece packing Assy, CO2RE | AS85421 | SYNERON MEDICAL LTD | GEX | 07290109950754 |
| External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima | KT77911 | SYNERON MEDICAL LTD | GEX | 17290109952823 |
| Handpiece external hygienic Packaged CO2RE | AS90245 | SYNERON MEDICAL LTD | GEX | 07290109952383 |
| 5-Pk, Internal hygienic, CO2RE Intima | KT76616 | Candela Corporation | GEX | 00817495024394 |
| Internal, CO2RE Intima | AS89732US | SYNERON MEDICAL LTD | GEX | 07290109950372 |
| CO2RE Intima | AS95201 | Candela Corporation | GEX | 00817495025063 |
| Hygienic Hand Piece Internal, Packaged, CO2RE Intima | AS89733US | SYNERON MEDICAL LTD | GEX | 07290109952390 |
| Intima hygienic Accessories Kit, CO2RE | KT77003 | Candela Corporation | GEX | 00817495024448 |
| Hand Piece, external, Packaged, CO2RE Intima | AS90244US | SYNERON MEDICAL LTD | GEX | 07290109950501 |
| Intima hygienic Accessories Kit, CO2RE | KT77003 | SYNERON MEDICAL LTD | GEX | 07290109952673 |
| Hygienic Hand Piece, external, Packaged, CO2RE Intima | AS90245US | SYNERON MEDICAL LTD | GEX | 07290109952406 |
| CO2RE Intima | AS89734 | Candela Corporation | GEX | 00817495024417 |
| Standard Hand-piece packing Assy, CO2RE | AS85421 | Candela Corporation | GEX | 00817495024356 |
| Standard 2 Hand-piece packing Assy, CO2RE | AS87532 | SYNERON MEDICAL LTD | GEX | 07290109952772 |
| Hand Piece Internal hygienic, Packaged, CO2RE | AS89733 | SYNERON MEDICAL LTD | GEX | 07290109952376 |
| Purple swivel lens | AS90411 | SYNERON MEDICAL LTD | GEX | 07290109950167 |
| Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima | KT77821 | Candela Corporation | GEX | 00817495024547 |
| Purple Swivel Lens CO2RE | AS90411 | Candela Corporation | GEX | 00817495024431 |
| CO2RE system | FG70412 | SYNERON MEDICAL LTD | GEX | 07290109950785 |