The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Glide Device.
| Device ID | K141242 |
| 510k Number | K141242 |
| Device Name: | GLIDE DEVICE |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | HOME SKINOVATIONS LTD. 20 HATA'AS STR., SUITE 102 Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein HOME SKINOVATIONS LTD. 20 HATA'AS STR., SUITE 102 Kfar Saba, IL 44425 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-14 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08712856055715 | K141242 | 000 |
| 00074590550863 | K141242 | 000 |
| 00075020040312 | K141242 | 000 |
| 07290015418461 | K141242 | 000 |
| 07290015418515 | K141242 | 000 |
| 07290015418867 | K141242 | 000 |
| 07290015764032 | K141242 | 000 |
| 07290015764520 | K141242 | 000 |
| 07290015764643 | K141242 | 000 |
| 07290016627084 | K141242 | 000 |
| 07290016627121 | K141242 | 000 |
| 07290016627381 | K141242 | 000 |
| 27290019840194 | K141242 | 000 |