Silk'n

Primary DI
17290019840036
Brand
Silk'n
Company
Silkn Beauty Ltd.
Model
BellaVisage Hybrid
Catalog number
7290019840039
Device description
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.
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162784000Silk'n HSTHome Skinovations , Ltd.2017-03-25OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019840039Direct MarkingGS10
17290019840036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019840039072900198400397290019840039
1729001984003617290019840036

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment system applicatorA handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-367-4556contact@silkn.com

Regulatory Flags#

DUNS number
473607052
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18712856075024Silk'nFM-0287128560750272026-05-07
07290019840428Silk'nFlash & Go Pro72900198404282026-05-06
17290019840029Silk'nInfinity Fast72900198400222024-01-10
17290019840043Silk'nFM-0272900198400462023-11-26
17290019840050Silk'nFM-0372900198400532023-11-26
17290019840142Silk'nBellaFlash Pro72900198401452024-05-05
17290019840159Silk'nFlash & Go Pro72900198401522024-05-05
17290019840197Silk'nMotion Premium72900198401902024-01-23
17290019840227Silk'nTitan Mini72900198402202024-01-30
17290019840234Silk'nTitan MultiPlatform72900198402372024-01-30
17290019840241Silk'nSilk'n 772900198402442024-01-30
17290019840258Silk'nSilk'n 772900198402512024-01-30
17290019840005Silk'nTitan AllWays72900198400082023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990143NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990167NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990181NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06974958310549ideatherapyShenzhen Idea Light LimitedOHS2026-04-17
06974958310556LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06974958310563LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
00850523007365CellumaBiophotas, Inc.OHS2026-04-06
05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHS2026-03-26
00850001456746Quantum Omm Imports Inc.OHS2026-03-02
07640260120600FAQ LED PanelForeo ABOHS2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOHS2026-03-02
06979826590016PMDDongguan Hunter Electronic Technology Co., Ltd.OHS2026-02-26