The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Polaris Lv, Lva Applicator.
| Device ID | K052324 |
| 510k Number | K052324 |
| Device Name: | POLARIS LV, LVA APPLICATOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. INDUSTRIAL ZONE P.O.B. 550 Yoqneam Illit, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman SYNERON MEDICAL LTD. INDUSTRIAL ZONE P.O.B. 550 Yoqneam Illit, IL 20692 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-09-14 |
| Summary: | summary |