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510(k) Data Aggregation
K Number
K231309Device Name
SCAR 3
Manufacturer
Date Cleared
2023-06-02
(28 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
El.en Electroinc Engineering Spa
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Acne scars
- · Surgical scars
Device Description
The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers.
The SCAR 3 is composed of the following components:
- HiScan SCAR 3 head
- HiScan SCAR 3 cable
Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.
Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
The modification to the device consists in the extension of the DEKA CO2 laser whom the SCAR 3 scanner can be connected to. The predicate device SCAR 3 (K211362) has been cleared to be used specifically in conjunction with DEKA Smartxide family; the proposed SCAR 3 scanner can be connected to all DEKA CO2 lasers.
The indications for use of the modified device remain the same. Modification only extends the range of CO2 laser the scanner can be used with.
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