The following data is part of a premarket notification filed by El Global Trade Ltd. with the FDA for Sensilight Mini.
| Device ID | K140527 |
| 510k Number | K140527 |
| Device Name: | SENSILIGHT MINI |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | EL GLOBAL TRADE LTD. TZORAN 4TH ST. Netanya, IL 42504 |
| Contact | Shlomit Segman |
| Correspondent | Shlomit Segman EL GLOBAL TRADE LTD. TZORAN 4TH ST. Netanya, IL 42504 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-07-31 |
| Summary: | summary |