FDA.reportPublic FDA data

Silk'n

Primary DI
17290019840227
Brand
Silk'n
Company
Silkn Beauty Ltd.
Model
Titan Mini
Catalog number
7290019840220
Device description
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared, and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles.The device has a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device has a rechargeable battery and is for cordless use only. A wall adapter is supplied to charge the device.
Published
2024-01-30
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
K230013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230013000Silk'n Titan AllwaysSilk'N Beauty , Ltd.2023-08-30PAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019840220Direct MarkingGS10
27290019840224PackageGS16In Commercial Distribution
17290019840227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019840220072900198402207290019840220
2729001984022427290019840224
1729001984022717290019840227

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 Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-250-5053customercarena@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
17290019840036Silk'nBellaVisage Hybrid72900198400392023-08-15
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
17290019840234Silk'nTitan MultiPlatform72900198402372024-01-30
17290019840241Silk'nSilk'n 772900198402442024-01-30
17290019840258Silk'nSilk'n 772900198402512024-01-30
17290019840005Silk'nTitan AllWays72900198400082023-09-14

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