silkn.com
sisloy.com
xx.xxSilk?n Toothwave
Home Skinovations , Ltd.
Home Skinovations Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006815171 | 3006815171 | Home Skinovations Inc. | 1 | Y | 2020-04-25 | 2815 Forbs Ave, suite 107 Hoffman Estates, Hoffman Est IL US 60192 |
| 3006948334 | 3006948334 | HOME SKINOVATIONS LTD. | 1 | N | 2020-04-25 | Tavor Bldg (POB 533) Shaar Yokneam Yokneam Ha Zafon IL 2069206 |
| 3012203407 | 3012203407 | HOME SKINOVATIONS CORP. | 1 | N | 2020-04-25 | 100 Leek Crescent, Unit 15, Richmond Hill Ontario Ontario CA ONL4B3E6 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10074590550860 | Remington - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-877-367-4556 | contact@silkn.com |
| 10075020040319 | PHILIPS - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-800-243-7884 | xx@xx.xx |
| 10866057000311 | SISLOY - An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. | 1-877-792-2761 | contact@sisloy.com |
| 17290015418468 | Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-877-367-4556 | contact@silkn.com |
| 17290015418512 | Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-877-367-4556 | contact@silkn.com |
| 17290015418864 | Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-877-367-4556 | contact@silkn.com |
| 17290015763858 | Silk'n - The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles. | 1-877-367-4556 | contact@silkn.com |
| 17290015764039 | Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime. | 1-877-367-4556 | contact@silkn.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 229857 | 1106385880 | K180279 | Silk'n MODEL H5003 device | NGX | 2018-05-09 |
| 85188 | 1106385880 | K180279 | Silk'n MODEL H5003 device | NGX | 2018-05-09 |
| 229857 | 1638456145 | K171433 | Silk'n Infinity | OHT | 2017-08-11 |
| 85188 | 1638456145 | K171433 | Silk'n Infinity | OHT | 2017-08-11 |
| 229857 | 1691507481 | K162784 | Silk'n HST | OHS | 2017-03-25 |
| 85188 | 1691507481 | K162784 | Silk'n HST | OHS | 2017-03-25 |
| 229857 | 1454033346 | K152087 | HeatLux Pro II | ILY | 2016-07-29 |
| 85188 | 1454033346 | K152087 | HeatLux Pro II | ILY | 2016-07-29 |
| 229857 | 1102424377 | K150175 | HeatLux Pro I | ILY | 2015-03-31 |
| 85188 | 1102424377 | K150175 | HeatLux Pro I | ILY | 2015-03-31 |
| 85188 | 1172660857 | K141242 | GLIDE DEVICE | OHT | 2014-10-17 |
| 229857 | 1172660857 | K141242 | GLIDE DEVICE | OHT | 2014-10-17 |
| 85188 | 1334253160 | K131870 | GLIDE DEVICE | OHT | 2013-08-14 |
| 229857 | 1334253160 | K131870 | GLIDE DEVICE | OHT | 2013-08-14 |
| 85188 | 1180563827 | K121435 | SILKN BLUE | OLP | 2013-02-22 |
| 229857 | 1180563827 | K121435 | SILKN BLUE | OLP | 2013-02-22 |
| 229857 | 1715975502 | K120582 | HEATLUX | ILY | 2012-07-06 |
| 85188 | 1715975502 | K120582 | HEATLUX | ILY | 2012-07-06 |
| 85188 | 1731409475 | K110301 | SILK'N FX | OHS | 2011-08-19 |
| 229857 | 1731409475 | K110301 | SILK'N FX | OHS | 2011-08-19 |
| 229857 | 1815965839 | K103184 | SILK'N FLASH N GO | OHT | 2010-11-10 |
| 85188 | 1815965839 | K103184 | SILK'N FLASH N GO | OHT | 2010-11-10 |
| 85188 | 1746597012 | K082298 | FLASH N' GO | GEX | 2008-10-23 |
| 229857 | 1746597012 | K082298 | FLASH N' GO | GEX | 2008-10-23 |
| 229857 | 1313940771 | K072906 | SILK'N | GEX | 2008-01-23 |
| 85188 | 1313940771 | K072906 | SILK'N | GEX | 2008-01-23 |
| 229857 | 1586333136 | ||||
| 85188 | 1586333136 | ||||
| 229857 | 1793717576 | ||||
| 85188 | 1793717576 | ||||
| 229857 | 2047727178 | ||||
| 85188 | 2047727178 |
Product Codes Associated With Registrations#
PMN#
Silk'n MODEL H5003 Device
Home Skinovations Ltd.
Silk'n Infinity
Home Skinovations Ltd.
Silk'n HST
Home Skinovations Ltd.
HeatLux Pro II
HOME SKINOVATIONS LTD.
HeatLux Pro I
HOME SKINOVATIONS LTD.
GLIDE DEVICE
HOME SKINOVATIONS LTD.
GLIDE DEVICE
HOME SKINOVATIONS LTD.
SILKN BLUE
HOME SKINOVATIONS LTD.
HEATLUX
HOME SKINOVATIONS LTD.
SILK'N FX
HOME SKINOVATIONS LTD.
SILK'N FLASH N GO
HOME SKINOVATIONS LTD.
FLASH N' GO
HOME SKINOVATIONS LTD.
SILK'N
HOME SKINOVATIONS LTD.
GUDID#
Remington - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-07-12
PHILIPS - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
SISLOY - An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
2017-06-18
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-04-26
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
2017-05-09
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-04-26
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
2018-12-19
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2018-01-25
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2018-01-25
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-07-12
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
2018-01-25
PREMIER (AVOLOGI) - An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
2017-01-26
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
2020-06-17
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-07-12
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
2020-06-17
Silk'n - The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
2021-08-08
Silk'n - The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and acontrol button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
2021-08-02
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
2016-12-13
Silk'n - An over the counter phototherapy device for the treatment of mild to moderate acne.
2016-08-15
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
2016-08-15
Silk'n - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of treatment regime.The electric output is indicated for facial stimulation for over-the-counter aesthetic use.
2018-01-25
Silk'n - The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
2018-10-18
Silk'n - 2 Bricks with accessories
2018-05-27
Silk'n - 1 Brick with accessories
2018-06-11
Silk'n - 1 Brick without accessories
2018-06-11
TONEm - 2 Bricks with accessories
2020-07-01
Silk'n - Tightra NA
2018-11-04
Silk'n - ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
2021-05-19
Silk'n - ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
2021-05-19
Silk'n - An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
2017-10-18
Solio - An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
2019-05-06
Silk'n - An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
2016-12-13
TONEm - 2 Bricks with accessories
2020-07-01
Remington - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2017-07-12
PHILIPS - An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
2016-08-15