HOME SKINOVATIONS LTD

Address:Tavor Bldg (POB 533),Yokneam Northern,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Light Based Over The Counter Wrinkle Reduction (OHS) (2) Light Based Over-The-Counter Hair Removal (OHT) (2) Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction (PAY) (2) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1) Powered Radiofrequency Toothbrush (QMJ) (1)

Premarket Exempt

No Yes

Clear

Silk'n - 17290112450552 Catalog Number : 7290112450555

Device Description : An over the counter device intended for the removal of unwanted hair. Also inten 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.

Device Class :

Duns Number: 514891048

Premarket Exempt : No

Product Code : OHT

Prescription Use : No

Device Count : 1

Silk'n - 17290112451559 Catalog Number : 7290112451552

Device Description : The Silk'n Titan Allways is an over-the-counter home use device intended for non 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.

Device Class :

Duns Number: 514891048

Premarket Exempt : No

Product Code : PAY, OHS

Prescription Use : No

Device Count : 1

Silk'n - 17290112451672 Catalog Number : 7290112451675

Device Description : ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral 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.

Device Class :

Duns Number: 514891048

Premarket Exempt : No

Product Code : QMJ

Prescription Use : No

Device Count : 1

Silk'n - 17290112452013 Catalog Number : 7290112452016

Device Description : The BellaVisage Hybrid is an over-the-counter home use device intended for non-i 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.

Device Class :

Duns Number: 514891048

Premarket Exempt : No

Product Code : PAY, OHS

Prescription Use : No

Device Count : 1

Silk'n - 18712856055712 Catalog Number : 8712856055715

Device Description : An over the counter device intended for the removal of unwanted hair. Also inten 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.

Device Class :

Duns Number: 514891048

Premarket Exempt : No

Product Code : ONF, OHT

Prescription Use : No

Device Count : 1

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