FDA.reportPublic FDA data

LUSTRE

Primary DI
05060282690325
Brand
LUSTRE
Company
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Model
PR7001
Device description
The LUSTRE® ClearSkin REVIVE mask has two settings to allow you to create a personalised skincare session.Select the BLUE setting to fight against dull looking skinand reveal a fresher and revived complexion.
Published
2025-03-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060282690325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060282690325050602826903255060282690325

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
543062382
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
00731093153129CurrentBody Skin™MZ-07M2026-06-27
00850079561014CurrentBody Skin™ZLD-72B2026-06-27
00860011935582CurrentBody Skin™MZ-07AM2026-06-27
00860011935599CurrentBody Skin™MZ-07AL2026-06-27
06970006973285CurrentBody Skin™MZ-07L2026-06-27
00850049532440HIGHERDOSEHG-120K2025-06-28
00731093153136CurrentBody Skin™MZ-072024-01-30
00695866567110CurrentBody Skin™EY-36B2025-06-28
00810137610429SOLAWAVEEY-20N2025-06-28
00810137610436SOLAWAVE610432025-06-28
00850049532471HIGHERDOSEMK66-L2025-06-28
00850062024557EXOCEUTICALSSZ-22A2025-06-28
00856957008022Dr NaomiMK-042025-06-28
05060282690301LustrePR60012025-06-28
05060282690318LustrePR50012025-06-28
06970006970918NOOANCEM-2822025-06-28
06970006970925NOOANCEM-1202025-06-28
06970006971144CosmotologyEY-20R2025-06-28
06970006971212EnergyLoungerTY-012025-06-28
00843041136433Tommie copper5008LD2022-01-26

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Primary DI, Brand, Company table
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10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOLP2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
09361725025404BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
09361725025411BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
05060534511521ELEMIS Red Light MaskI-SMART DEVELOPMENTS LIMITEDOHS2026-08-07
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
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