Company · IL
Home Skinovations , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 4 |
| ILY | Lamp, Infrared, Therapeutic Heating | 3 |
| GEX | Powered Laser Surgical Instrument | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 |
| QMJ | Powered Radiofrequency Toothbrush | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2023 | K214078 | Silkn Toothwave Home Skinovations , Ltd., IL | QMJ |
| Sep 17, 2020 | DEN190039 | ToothWave Home Skinovations , Ltd., IL | QMJ |
| May 9, 2018 | K180279 | Silk'n MODEL H5003 device Home Skinovations , Ltd., IL | NGX |
| Aug 11, 2017 | K171433 | Silk'n Infinity Home Skinovations , Ltd., IL | OHT |
| Mar 25, 2017 | K162784 | Silk'n HST Home Skinovations , Ltd., IL | OHS |
| Jul 29, 2016 | K152087 | HeatLux Pro II Home Skinovations , Ltd., IL | ILY |
| Mar 31, 2015 | K150175 | HeatLux Pro I Home Skinovations , Ltd., IL | ILY |
| Oct 17, 2014 | K141242 | GLIDE DEVICE Home Skinovations , Ltd., IL | OHT |
| Aug 14, 2013 | K131870 | GLIDE DEVICE Home Skinovations , Ltd., IL | OHT |
| Feb 22, 2013 | K121435 | SILKN BLUE Home Skinovations , Ltd., IL | OLP |
| Jul 6, 2012 | K120582 | HEATLUX Home Skinovations , Ltd., IL | ILY |
| Aug 19, 2011 | K110301 | SILK'N FX Home Skinovations , Ltd., IL | OHS |
| Nov 10, 2010 | K103184 | SILK'N FLASH N GO Home Skinovations , Ltd., IL | OHT |
| Oct 23, 2008 | K082298 | FLASH N' GO Home Skinovations , Ltd., IL | GEX |
| Jan 23, 2008 | K072906 | SILK'N Home Skinovations , Ltd., IL | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||