The following data is part of a premarket notification filed by Syneron, Ltd. with the FDA for Eplus Skin Treatment System.
Device ID | K113868 |
510k Number | K113868 |
Device Name: | EPLUS SKIN TREATMENT SYSTEM |
Classification | Powered Laser Surgical Instrument |
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 | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-30 |
Decision Date | 2012-06-11 |
Summary: | summary |