Search Results
Found 3 results
510(k) Data Aggregation
K Number
K241400Device Name
SkinPen Precision Elite System
Manufacturer
Crown Aesthetics
Date Cleared
2024-08-29
(104 days)
Product Code
QAI
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Crown Aesthetics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SkinPen® Precision Elite system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 vears and older.
Device Description
The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.
Ask a Question
K Number
K220506Device Name
SkinPen Precision System
Manufacturer
Crown Aesthetics
Date Cleared
2022-03-07
(13 days)
Product Code
QAI, NAE
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Crown Aesthetics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
Device Description
The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.); Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.); SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.; Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.
Ask a Question
K Number
K202243Device Name
SkinPen Precision System
Manufacturer
Crown Aesthetics
Date Cleared
2021-04-02
(235 days)
Product Code
QAI, NAE
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Crown Aesthetics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
Device Description
The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.
Ask a Question
Page 1 of 1