IBORRIA

Primary DI
06974639600495
Brand
IBORRIA
Company
SHENZHEN BORRIA TECHNOLOGY CO.,LTD
Model
M226
Device description
The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow band of light for the treatment of cosmetic indications including facial wrinkles and acnes. The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Type-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller. The LEDs generate 4 kinds of light which include Blue light (460nm, only suitable model M226 and MN1 LED Facial Mask), Red light (630nm), Infrared light (850nm) and Mixed light (630nm and 850nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED output. And the straps used for securing the mask unit to the body part.
Published
2026-08-27
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
K242385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242385000LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.2025-04-07OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974639600495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974639600495069746396004956974639600495

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
+86075583167375Hello@iborria.com

Regulatory Flags#

DUNS number
715959366
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974639600464IBORRIABR20202026-08-27
06974639600471IBORRIABR2232026-08-27
06974639600488IBORRIABR2252026-08-27
06974639600501IBORRIAMN12026-08-27

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