FDA.reportPublic FDA data

ESTHELA

Primary DI
06980299090026
Brand
ESTHELA
Company
Shaoxing Chongsu E-Commerce Co., Ltd.
Model
Radiance A
Catalog number
30203-P
Device description
ESTHELA Radiance A LED Light Therapy Mask (Pink) is an over-the-counter (OTC) home use device intended for the treatment of wrinkles and acne. Contains: LED Face Mask, Eye Shield, Carrying Bag, Controller, User Manual, and USB Charging Cable.
Published
2026-08-14
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

Contact Domains#

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
K261407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261407000XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)Dongguan Miqiang Technology Co., Ltd.2026-07-15OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980299090026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980299090026069802990900266980299090026

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.

Contacts#

Phone, Email table
PhoneEmail
9999999999support@esthelabeauty.com

Regulatory Flags#

DUNS number
619266248
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06980299090002ESTHELARadiance A30201-W2026-08-14
06980299090019ESTHELARadiance A30202-B2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063090RenphoJoicom CorporationOHS2026-06-23
00810140063090RenphoJoicom CorporationOLP2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02