Shenzhen Wells Optoelectronics Co.,Ltd.

Primary DI
06977182810113
Brand
Shenzhen Wells Optoelectronics Co.,Ltd.
Company
Shenzhen Wells Optoelectronics Co.,Ltd.
Model
DZ01
Device description
derma pen/DZ01
Published
2024-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNMDevice, Pressure Applying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977182810113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977182810113069771828101136977182810113

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549645451
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977182812018Shenzhen Wells Optoelectronics Co.,Ltd.IR2012024-06-16
06977182819192Shenzhen Wells Optoelectronics Co.,Ltd.919AS2024-06-16
06977182819390Shenzhen Wells Optoelectronics Co.,Ltd.9392024-06-16
16977182810073Shenzhen Wells Optoelectronics Co.,Ltd.CD07S2024-06-16
06977182810014Shenzhen Wells Optoelectronics Co.,Ltd.DZ-012024-06-11

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