FDA.reportPublic FDA data

Brookstone

Primary DI
06974020961372
Brand
Brookstone
Company
Guangdong Newdermo Biotech Co.,Ltd.
Model
FM-01
Device description
LED light therapy mask
Published
2026-05-28
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
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
16974020961379PackageGS112In Commercial Distribution
06974020961372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697402096137916974020961379
06974020961372069740209613726974020961372

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 Humidity00
Handling Environment Temperature00

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
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
16974020960914NewdermoFM-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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18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
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00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
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B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
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