SCAR 3

El.En Electroinc Engineering Spa

Country / region:Italy (IT)Submission type:Special

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K231309
Device name
SCAR 3
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-05-05
Decision date
2023-06-02
Submission type
Special
Technology type
CO2(AI inferred)
Clinical applications
Skin resurfacingSurgical cutting
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The SCAR 3 scanner, when used with DEKA CO2 lasers, 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 CO2 lasers, 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 CO2 lasers, 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 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.

Summary parsed at:2026-06-01 05:32:59 UTC

Predicate devices

2

K231309 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K231309 as a predicate