FDA.reportPublic FDA data

N/A

Primary DI
06974020961105
Brand
N/A
Company
Guangdong Newdermo Biotech Co.,Ltd.
Model
FM-02
Device description
FM-02 ; LED light therapy mask
Published
2025-09-26
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
ILYLamp, Infrared, Therapeutic Heating
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
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
06974020961105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974020961105069740209611056974020961105

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00810140063090RenphoJoicom CorporationOHS2026-06-23
00810140063090RenphoJoicom CorporationOLP2026-06-23
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27