The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Polaris Wr.
| Device ID | K031671 |
| 510k Number | K031671 |
| Device Name: | POLARIS WR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-29 |
| Decision Date | 2003-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951973 | K031671 | 000 |
| 07290109951454 | K031671 | 000 |
| 07290109951249 | K031671 | 000 |
| 07290109950112 | K031671 | 000 |
| 07290109950105 | K031671 | 000 |