FDA.reportPublic FDA data

Project E Beauty

Primary DI
04897111807354
Brand
Project E Beauty
Company
DUPLEX INTERNATIONAL TRADING LIMITED
Model
PE762
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K254025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254025000LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-06-16OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897111807354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897111807354048971118073544897111807354

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.

Regulatory Flags#

DUNS number
663700319
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOHS2026-09-21
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.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
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.OHS2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
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