Manufacturer
El.En Electronic Engineering SpaSCAR 3
El.En Electronic Engineering Spa
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K211362
- Device name
- SCAR 3
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-05-03
- Decision date
- 2021-08-25
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for 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 (K 180193), 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
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 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.
Summary parsed at:2026-06-01 05:43:02 UTC
Predicate devices
2The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
K211362 references 2 predicate/reference devices
Cited as predicate
11 submission cite K211362 as a predicate
