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 |