The following data is part of a premarket notification filed by Syneron-candela Corp with the FDA for Syneron Co2re System.
| Device ID | K181523 |
| 510k Number | K181523 |
| Device Name: | Syneron CO2RE System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Syneron-Candela Corp 530 Boston Post Road Wayland, MA 01778 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake Syneron-Candela Corp 530 Boston Post Road Wayland, MA 01778 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495024271 | K181523 | 000 |
| 00817495024547 | K181523 | 000 |
| 00817495024554 | K181523 | 000 |
| 00817495025056 | K181523 | 000 |
| 00817495025063 | K181523 | 000 |
| 07290109950730 | K181523 | 000 |
| 07290109950754 | K181523 | 000 |
| 17290109952373 | K181523 | 000 |
| 17290109952380 | K181523 | 000 |
| 00817495024523 | K181523 | 000 |
| 00817495024431 | K181523 | 000 |
| 00817495024424 | K181523 | 000 |
| 00817495024448 | K181523 | 000 |
| 00817495024264 | K181523 | 000 |
| 00817495024288 | K181523 | 000 |
| 00817495024356 | K181523 | 000 |
| 00817495024363 | K181523 | 000 |
| 00817495024394 | K181523 | 000 |
| 00817495024400 | K181523 | 000 |
| 00817495024417 | K181523 | 000 |
| 07290109950167 | K181523 | 000 |
| 07290109950273 | K181523 | 000 |
| 07290109952666 | K181523 | 000 |
| 07290109952673 | K181523 | 000 |
| 07290109952765 | K181523 | 000 |
| 07290109952772 | K181523 | 000 |
| 07290109952833 | K181523 | 000 |
| 17290109950379 | K181523 | 000 |
| 07290109952857 | K181523 | 000 |
| 17290109952724 | K181523 | 000 |
| 07290109952413 | K181523 | 000 |
| 17290109952403 | K181523 | 000 |
| 17290109952397 | K181523 | 000 |
| 07290109950280 | K181523 | 000 |
| 07290109950372 | K181523 | 000 |
| 07290109950501 | K181523 | 000 |
| 07290109950518 | K181523 | 000 |
| 07290109950655 | K181523 | 000 |
| 07290109950747 | K181523 | 000 |
| 07290109950785 | K181523 | 000 |
| 07290109952116 | K181523 | 000 |
| 17290109952823 | K181523 | 000 |