CODE-X

Primary DI
08800118100355
Brand
CODE-X
Company
Woorhi Mechatronics Co., Ltd.
Model
CODE-X
Device description
The CODE-X Automatic Micro Needle System is a motorized, AC-powered microneedling device designed to mechanically create microscopic channels in the epidermal and upper dermal layers of the skin for aesthetic use. The device delivers controlled microneedle penetration through a reciprocating needle cartridge driven by the motorized handpiece with embedded microprocessor control. The system consists of the following components: • Motorized handpiece (reusable) with adjustable needle depth control • Sterile, single-use disposable microneedle cartridges (12-pin and 14-pin, EO sterilized)
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252591000Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.2026-05-13QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800118100355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800118100355088001181003558800118100355

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece, professionalA hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
0314575032sales@woorhimecha.com

Regulatory Flags#

DUNS number
557837985
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800118100348NAWNTR-122026-09-04
08800118100560NAWNTR-142026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800118100348NAWoorhi Mechatronics Co., Ltd.QAI2026-09-04
08800118100560NAWoorhi Mechatronics Co., Ltd.QAI2026-09-04
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00810007534954SKINSTYLUS STERILOCK HILO CARTRIDGE IN POUCHHydrafacial LLCQAI2026-08-19
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EMTDEMNPA4906USMP06-MNP 1.5 Exceed USMT.DERM GmbHQAI2026-05-22
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
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08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.QAI2026-04-29
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCQAI2026-03-27
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080555980600821NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
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04260446131058XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
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