The following data is part of a premarket notification filed by Syneron, Ltd. with the FDA for Etwo Skin Treatment System.
Device ID | K110672 |
510k Number | K110672 |
Device Name: | ETWO SKIN TREATMENT SYSTEM |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | SYNERON, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
Contact | Yoram Levy |
Correspondent | Yoram Levy SYNERON, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-09 |
Decision Date | 2011-10-03 |
Summary: | summary |