FDA.reportPublic FDA data

Silk'n

Primary DI
07290015763851
Brand
Silk'n
Company
HOME SKINOVATIONS LTD
Model
Titan
Catalog number
7290015763851
Device description
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.
Published
2017-05-09
Public version status
Update
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
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
07290015763851Direct MarkingGS10
27290015763855PackageGS16In Commercial Distribution
17290015763858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015763851072900157638517290015763851
2729001576385527290015763855
1729001576385817290015763858

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin?s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.

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
1-877-367-4556contact@silkn.com

Regulatory Flags#

DUNS number
514891048
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
10074590550860RemingtonIPL350000745905508632017-07-12
10075020040319PHILIPSLumea Comfort SC19810750200403122016-08-15
10866057000311SISLOYSupreme8660570003142017-06-18
17290015418468Silk'nFlash & Go Compact72900154184612016-08-15
17290015418512Silk'nGlide 150K Brazil72900154185152017-04-26
17290015418864Silk'nFlash & Go Express 72900154188672016-08-15
17290015763858Silk'nTitan72900157638512017-05-09
17290015764039Silk'nGlide Express Brazil 72900157640322017-04-26
17290015764527Silk'nBellaGlide72900157645202016-08-15
17290015764633Silk'nFaceFX 36072900157646362018-12-19
17290015764640Silk'nJewel72900157646432016-08-15
17290016627081Silk'nBellaFlash Pro72900166270842018-01-25
17290016627128Silk'nFlash & Go Pro72900166271212018-01-25
17290016627388Silk'nBellaGlide72900166273812017-07-12
17290016627852Silk'nFlash & Go LUXX72900166278552018-01-25
17290106259215PREMIER (AVOLOGI)Renelif72901062592182017-01-26
17290112450552Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
18712856055712Silk'nGlide87128560557152017-07-12
27290112450559Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
17290112452013Silk'n BellaVisage Hybrid72901124520162021-08-08

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
27290019840231Silk'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