FDA.reportPublic FDA data

Silk'n

Primary DI
18712856075024
Brand
Silk'n
Company
Silkn Beauty Ltd.
Model
FM-02
Catalog number
8712856075027
Device description
LED Light Therapy Mask
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILPSystem, Communication, Non-Powered
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILPSystem, Communication, Non-PoweredPhysical Medicine1
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, 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
08712856075027PackageGS16In Commercial Distribution
18712856075024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08712856075027087128560750278712856075027
1871285607502418712856075024

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

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
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
17290019840241Silk'nSilk'n 772900198402442024-01-30
17290019840258Silk'nSilk'n 772900198402512024-01-30
17290019840005Silk'nTitan AllWays72900198400082023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOLP2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
09361725025404BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
09361725025411BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
05060534511521ELEMIS Red Light MaskI-SMART DEVELOPMENTS LIMITEDOHS2026-08-07
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16