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510(k) Data Aggregation
K Number
K211362Device Name
SCAR 3
Manufacturer
Date Cleared
2021-08-25
(114 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EL. En Electronic Engineering SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, incision, 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 the Deka SmartXide family lasers (K180193).
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.
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