The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Sensilight Mini.
| Device ID | K161089 |
| 510k Number | K161089 |
| Device Name: | SensiLight Mini |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | EL GLOBAL TRADE LTD 8 TZORAN ST, P.O. BOX 8242 Netanya, IL 4250604 |
| Contact | Yael Liebes-peer |
| Correspondent | Yael Liebes-peer EL GLOBAL TRADE LTD 8 TZORAN ST, P.O. BOX 8242 Netanya, IL 4250604 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-07-08 |
| Summary: | summary |