FDA.reportPublic FDA data

DemarkQ

Primary DI
08720299044227
Brand
DemarkQ
Company
Light Tree Ventures Europe B.V.
Model
P19-0007
Device description
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Published
2022-04-01
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
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203214000DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO , Ltd.2021-07-22OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720299044227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299044227087202990442278720299044227

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

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
05060282690288RENEW Pro Facewear MaskPR40012024-03-05
08719327598719Q-Rejuvalight Pro FacewearP19-00232024-03-05

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