FDA.reportPublic FDA data

RENEW Pro Facewear Mask

Primary DI
05060282690288
Brand
RENEW Pro Facewear Mask
Company
Light Tree Ventures Europe B.V.
Model
PR4001
Published
2024-03-05
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
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
K230124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230124000LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)Light Tree Ventures Europe B.V.2023-03-15OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060282690288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060282690288050602826902885060282690288

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
493246808
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09361725008346BON CHARGEYS-062026-05-25
09361725008360BON CHARGEYS-06A2026-05-25
08719327598719Q-Rejuvalight Pro FacewearP19-00232024-03-05
08720299044227DemarkQP19-00072022-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
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.OHS2026-04-06
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
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