The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Micro Ipl.
Device ID | K172181 |
510k Number | K172181 |
Device Name: | Micro IPL |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | EL Global Trade Ltd 8 Tzoran St, P.O.Box 8242 Netanya, IL 4250608 |
Contact | Yael Liebes |
Correspondent | Yael Liebes EL Global Trade Ltd 8 Tzoran St, P.O.Box 8242 Netanya, IL 4250608 |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-19 |
Decision Date | 2017-10-13 |
Summary: | summary |