FDA.reportPublic FDA data

Silk'n

Primary DI
17290019840241
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
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
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
OTHOxidized Cellulose Mesh/Pad

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
OTHOxidized Cellulose Mesh/Pad

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

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
17290019840227Silk'nTitan Mini72900198402202024-01-30
17290019840234Silk'nTitan MultiPlatform72900198402372024-01-30
17290019840258Silk'nSilk'n 772900198402512024-01-30
17290019840005Silk'nTitan AllWays72900198400082023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019840428Silk'nSilkn Beauty Ltd.ONF2026-05-06
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
00851530007638AvazziaAVAZZIA INCNFO2026-04-21
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
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
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDONF2026-04-08
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.ONF2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
07290117772645Black Stellar XPL HPLUMENIS BE LTDONF2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDONF2025-09-08
07290016633313Plus ApplicatorINMODE M.D LTDONF2025-07-27
06974667825013JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825020JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825037JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825044JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825051JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15