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 |