The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Polaris Wr, St Applicator.
| Device ID | K053616 |
| 510k Number | K053616 |
| Device Name: | POLARIS WR, ST APPLICATOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. APPOLO BLDG., INDUSTRIAL ZONE Yoqneam Illit, IL |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman SYNERON MEDICAL LTD. APPOLO BLDG., INDUSTRIAL ZONE Yoqneam Illit, IL |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-28 |
| Decision Date | 2006-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951362 | K053616 | 000 |
| 07290109950037 | K053616 | 000 |