The following data is part of a premarket notification filed by El Global Trade Ltd. with the FDA for Sensilight/ Sensilight Plus.
| Device ID | K140381 |
| 510k Number | K140381 |
| Device Name: | SENSILIGHT/ SENSILIGHT PLUS |
| 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 | 2014-02-14 |
| Decision Date | 2014-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060445340029 | K140381 | 000 |
| 05060445340005 | K140381 | 000 |