The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Glide Device.
| Device ID | K131870 |
| 510k Number | K131870 |
| Device Name: | GLIDE DEVICE |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | HOME SKINOVATIONS LTD. 20 HATA'AS STR., STE 102 Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein HOME SKINOVATIONS LTD. 20 HATA'AS STR., STE 102 Kfar Saba, IL 44425 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-08-14 |
| Summary: | summary |