The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Matrix Rf Applicator.
| Device ID | K090025 |
| 510k Number | K090025 |
| Device Name: | MATRIX RF APPLICATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
| Contact | Yoni Iger |
| Correspondent | Yoni Iger SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-05 |
| Decision Date | 2010-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952208 | K090025 | 000 |
| 07290109950662 | K090025 | 000 |
| 07290109950648 | K090025 | 000 |
| 07290109950631 | K090025 | 000 |
| 07290109950624 | K090025 | 000 |
| 07290109950617 | K090025 | 000 |
| 07290109950013 | K090025 | 000 |
| 37290109952209 | K090025 | 000 |
| 37290109952193 | K090025 | 000 |
| 37290109952186 | K090025 | 000 |
| 37290109952179 | K090025 | 000 |
| 37290109951219 | K090025 | 000 |
| 37290109951202 | K090025 | 000 |
| 37290109951196 | K090025 | 000 |
| 07290109950679 | K090025 | 000 |
| 07290109950709 | K090025 | 000 |
| 07290109952192 | K090025 | 000 |
| 07290109952185 | K090025 | 000 |
| 07290109952178 | K090025 | 000 |
| 07290109952017 | K090025 | 000 |
| 07290109951591 | K090025 | 000 |
| 07290109951577 | K090025 | 000 |
| 07290109951256 | K090025 | 000 |
| 07290109951225 | K090025 | 000 |
| 07290109951218 | K090025 | 000 |
| 07290109951201 | K090025 | 000 |
| 07290109951195 | K090025 | 000 |
| 07290109951188 | K090025 | 000 |
| 07290109950716 | K090025 | 000 |
| 37290109951189 | K090025 | 000 |