FDA.reportPublic FDA data

Silk'n

Primary DI
27290019840231
Brand
Silk'n
Company
SILKN BEAUTY LTD
Model
Titan MultiPlatform
Catalog number
7290019840237
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 includes a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device is provided with an RF Attachment which provides larger treatment surface. It has a rechargeable battery for cordless use, as well as a wall adapter for connection to the mains supply.
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
07290019840237Direct MarkingGS10
27290019840231PackageGS13In Commercial Distribution
17290019840234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019840237072900198402377290019840237
2729001984023127290019840231
1729001984023417290019840234

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-250-5053customercarena@silkn.com

Regulatory Flags#

DUNS number
625893101
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27290019840149Silk'nBellaFlash Pro72900198401452024-05-05
27290019840156Silk'nFlash & Go Pro72900198401522024-05-05
27290019840224Silk'nTitan Mini72900198402202024-01-30
27290019840248Silk'nSilk'n 772900198402442024-01-30
27290019840255Silk'nSilk'n 772900198402512024-01-30
27290019840194Silk'nMotion Premium72900198401902024-01-23
27290019840040Silk'nFM-0272900198400462023-11-26
27290019840057Silk'nFM-0372900198400532023-11-26
07290019840039Silk'nBellaVisage Hybrid72900198400392023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016586794MyLiftPOLLOGEN LTDPAY2026-02-22
07290016586817AURAPOLLOGEN LTDPAY2026-02-22
07290016586671GENEO, GLO2FACIAL, ELITEPOLLOGEN LTDPAY2025-02-11
07640260120044FAQ 102Foreo ABPAY2024-07-18
07640260120051FAQ 103Foreo ABPAY2024-07-18
07640260120112FAQ 102Foreo ABPAY2024-07-18
07640260120037FAQ 101Foreo ABPAY2024-03-01
17290019840227Silk'nSilkn Beauty Ltd.PAY2024-01-30
17290019840234Silk'nSilkn Beauty Ltd.PAY2024-01-30
27290019840224Silk'nSILKN BEAUTY LTDPAY2024-01-30
07290016586459Desire model UPOLLOGEN LTDPAY2023-12-15
07290016586626STOP VX2 MODEL U POLLOGEN LTDPAY2023-12-14
07290014660120NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290014660127NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290019840005Silk'nSilkn Beauty Ltd.PAY2023-09-14
17290019840036Silk'nSilkn Beauty Ltd.PAY2023-08-15
07290019840039Silk'nSILKN BEAUTY LTDPAY2023-08-15
07290014660113NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
17290014660110NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
07290016586466STOP VX GOLD MODEL UPOLLOGEN LTDPAY2021-11-07
07290014660083NEWA KitENDYMED MEDICAL LTDPAY2021-09-23
17290112452013Silk'n HOME SKINOVATIONS LTDPAY2021-08-08
17290112451559Silk'nHOME SKINOVATIONS LTDPAY2021-08-02
07290016586442STOP VX MODEL UPOLLOGEN LTDPAY2021-06-30
07290014660021NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
17290014660028NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
07290018007686STOP XPOLLOGEN LTDPAY2020-12-22
07290014660014NEWA PLUS KitENDYMED MEDICAL LTDPAY2019-11-24
07290018007303STOP XPOLLOGEN LTDPAY2019-11-07
17290112450224Silk'nHOME SKINOVATIONS LTDPAY2018-10-18