The following data is part of a premarket notification filed by Endymed Medical Ltd with the FDA for Glow By Endymed.
| Device ID | K120513 |
| 510k Number | K120513 |
| Device Name: | GLOW BY ENDYMED |
| Classification | Skin Resurfacing Rf Applicator |
| Applicant | ENDYMED MEDICAL LTD 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ENDYMED MEDICAL LTD 31 HAAVODA 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 | 2012-02-21 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016814293 | K120513 | 000 |
| 07290016814286 | K120513 | 000 |
| 07290016814279 | K120513 | 000 |
| 07290016814231 | K120513 | 000 |
| 07290016814057 | K120513 | 000 |
| 07290016814040 | K120513 | 000 |
| 07290016814033 | K120513 | 000 |
| 07290016814019 | K120513 | 000 |
| 07290016814668 | K120513 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLOW BY ENDYMED 76712346 4355793 Live/Registered |
ENDYMED MEDICAL LTD. 2012-09-05 |