The following data is part of a premarket notification filed by Endymed Medical Ltd with the FDA for Intensif.
| Device ID | K130501 |
| 510k Number | K130501 |
| Device Name: | INTENSIF |
| Classification | Skin Resurfacing Rf Applicator |
| Applicant | ENDYMED MEDICAL LTD HAAVODA 31 ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ENDYMED MEDICAL LTD HAAVODA 31 ST. Binyamina, IL 30500 |
| Product Code | OUH |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-27 |
| Decision Date | 2014-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016814330 | K130501 | 000 |
| 07290016814323 | K130501 | 000 |
| 07290016814217 | K130501 | 000 |
| 07290016814200 | K130501 | 000 |
| 07290016814415 | K130501 | 000 |