FDA.reportPublic FDA data

SUNVIVI

Primary DI
06977603320023
Brand
SUNVIVI
Company
Ningbo Dechang Electrical Machinery Made Co.,Ltd.
Model
RT01
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
K242068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242068000LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd2025-04-04OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977603320020PackageGS14In Commercial Distribution
06977603320023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697760332002016977603320020
06977603320023069776033200236977603320023

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.

Regulatory Flags#

DUNS number
544874472
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
06977603320030cosytimeRT012025-11-28
16977603320037cosytimeRT012025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
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 INCOLP2026-04-23
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
00850523007365CellumaBiophotas, Inc.OHS2026-04-06
05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
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.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdOHS2026-02-04
05060555750756LYMA LaserLYMA LIFE LIMITEDOLP2026-01-28
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.OLP2026-01-16
06920473100820ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100837ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100844ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100851ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100868ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100875ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100882ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100899ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100905ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
00850020752492NIRA Bundle +Nira Innovations IncorporatedOHS2025-11-19