FDA.reportPublic FDA data

Silk'n

Primary DI
27290019840248
Brand
Silk'n
Company
SILKN BEAUTY LTD
Model
Silk'n 7
Catalog number
7290019840244
Device description
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth.
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
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171433000Silk'n InfinityHome Skinovations , Ltd.2017-08-11OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019840244Direct MarkingGS10
27290019840248PackageGS14In Commercial Distribution
17290019840241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019840244072900198402447290019840244
2729001984024827290019840248
1729001984024117290019840241

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

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
27290019840231Silk'nTitan MultiPlatform72900198402372024-01-30
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

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Primary DI, Brand, Company table
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06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
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00817076014523bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
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