The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Aurora Sr And Sra Applicator.
| Device ID | K050452 |
| 510k Number | K050452 |
| Device Name: | AURORA SR AND SRA 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 | 2005-02-22 |
| Decision Date | 2005-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951331 | K050452 | 000 |
| 07290109950051 | K050452 | 000 |