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510(k) Data Aggregation
K Number
K230420Device Name
Dr. pen Microneedling System
Manufacturer
Guangzhou Ekai Electronic Technology Co., Ltd.
Date Cleared
2023-08-11
(176 days)
Product Code
QAI, OAI
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Ekai Electronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.
Device Description
The Dr.pen Microneedling System is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the Dr.pen pen body to the power adapter.
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