The following data is part of a premarket notification filed by El Global Trade Ltd. with the FDA for Sensilight Pro / Pistol Ipl.
| Device ID | K183260 |
| 510k Number | K183260 |
| Device Name: | Sensilight Pro / Pistol 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 | Shachar Raz |
| Correspondent | Shachar Raz 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 | 2018-11-23 |
| Decision Date | 2019-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060445341576 | K183260 | 000 |