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510(k) Data Aggregation
K Number
K243472Device Name
1NEED Pro
Manufacturer
Campomats S.r.l.
Date Cleared
2025-03-19
(131 days)
Product Code
QAI
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Campomats S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 1NEED Pro 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 or older.
Device Description
The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. 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 of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.
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