FDA.reportPublic FDA data

Silk'n

Primary DI
27290019840040
Brand
Silk'n
Company
SILKN BEAUTY LTD
Model
FM-02
Catalog number
7290019840046
Device description
LED Light Therapy Mask
Published
2023-11-26
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

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223544000LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.2023-02-23OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019840046Direct MarkingGS10
27290019840040PackageGS16In Commercial Distribution
17290019840043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019840046072900198400467290019840046
2729001984004027290019840040
1729001984004317290019840043

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

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
27290019840248Silk'nSilk'n 772900198402442024-01-30
27290019840255Silk'nSilk'n 772900198402512024-01-30
27290019840194Silk'nMotion Premium72900198401902024-01-23
27290019840057Silk'nFM-0372900198400532023-11-26
07290019840039Silk'nBellaVisage Hybrid72900198400392023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
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06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
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06974958310556LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06974958310563LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07