FDA.reportPublic FDA data

Newdermo

Primary DI
16974020960914
Brand
Newdermo
Company
Guangdong Newdermo Biotech Co.,Ltd.
Model
FM-01
Device description
LED light therapy mask
Published
2023-08-25
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
16974020960914PackageGS116In Commercial Distribution
06974020960917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697402096091416974020960914
06974020960917069740209609176974020960917

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
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
403370499
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
06974020961372BrookstoneFM-012026-05-28
06974020961280BrookstoneFM-012026-01-13
06974020961273BrookstoneFM-012026-01-04
06974020961075N/AFM-022025-09-26
06974020961082N/AFM-032025-09-26
06974020961105N/AFM-022025-09-26
06974020961037N/AFM-022024-07-28
16974020961034N/AFM-022024-07-28
06974020961044N/AFM-022024-07-28
06974020961068N/AFM-012024-07-28
06974020961020INIAFM-022024-03-18
06974020961006WONDER FAMILYFM-022023-10-16
16974020961003WONDER FAMILYFM-022023-10-16
06974020961013WONDER FAMILYFM-032023-10-16
06974020960917NewdermoFM-012023-08-25
06974020960962kingdoFM-022023-05-30
06974020960979kingdoFM-022023-06-01
06974020960986VOGUENOWFM-022023-05-30
06974020960993AURAFM-022023-05-30
06974020960955AURAFM-022023-05-25

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Primary DI, Brand, Company table
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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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05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHS2026-03-26
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07640260120600FAQ LED PanelForeo ABOHS2026-03-02
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