The following data is part of a premarket notification filed by Venus Concept Ltd with the FDA for Venus Freeze (mp)2 System.
Device ID | K111670 |
510k Number | K111670 |
Device Name: | VENUS FREEZE (MP)2 SYSTEM |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VENUS CONCEPT LTD 31 HAAVODA ST Binyamina, IL 30500 |
Contact | Yoram Levy |
Correspondent | Yoram Levy VENUS CONCEPT 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 | 2011-06-15 |
Decision Date | 2012-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290016540611 | K111670 | 000 |
07290016540253 | K111670 | 000 |
07290016540246 | K111670 | 000 |
07290016540239 | K111670 | 000 |
07290016540222 | K111670 | 000 |
07290016540192 | K111670 | 000 |
07290016540185 | K111670 | 000 |
07290016540178 | K111670 | 000 |
07290016540161 | K111670 | 000 |