FDA.reportPublic FDA data

NA

Primary DI
06974746830006
Brand
NA
Company
Ningbo Hesi Electronics Co., Ltd.
Model
HK207
Published
2021-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K200983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200983000Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty MachineNingbo Hesi Electric Co., Ltd.2021-07-14OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974746830006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974746830006069747468300066974746830006

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
415478393
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974746830027MOONTREEHS-G12023-01-31
06974746830037MOONTREEHKS1072023-01-31
06974746830044MOONTREEHKS1062023-01-31
06974746830013NAHK2092021-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOHS2026-02-06
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10