The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Co2re System.
| Device ID | K151655 |
| 510k Number | K151655 |
| Device Name: | CO2RE System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. Tavor Building, Industrial Zone, P.O.B. 550 Yokneam Lllit, IL 20692 |
| Contact | Ruthie Amir |
| Correspondent | Janice M Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952833 | K151655 | 000 |
| 07290109950747 | K151655 | 000 |
| 07290109950730 | K151655 | 000 |
| 07290109950655 | K151655 | 000 |
| 07290109950518 | K151655 | 000 |
| 07290109950501 | K151655 | 000 |
| 07290109950372 | K151655 | 000 |
| 07290109950280 | K151655 | 000 |
| 07290109950273 | K151655 | 000 |
| 07290109950167 | K151655 | 000 |
| 07290109950754 | K151655 | 000 |
| 07290109950785 | K151655 | 000 |
| 07290109952116 | K151655 | 000 |
| 07290109952772 | K151655 | 000 |
| 07290109952765 | K151655 | 000 |
| 07290109952673 | K151655 | 000 |
| 07290109952666 | K151655 | 000 |
| 07290109952413 | K151655 | 000 |
| 17290109952403 | K151655 | 000 |
| 17290109952397 | K151655 | 000 |
| 17290109952380 | K151655 | 000 |
| 17290109952373 | K151655 | 000 |
| 17290109950379 | K151655 | 000 |