# K231309: SCAR 3

- Pathway: 510(k) (Special)
- Applicant: El.En Electroinc Engineering Spa
- Decided: Jun 2, 2023 after 28 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211362: SCAR 3, El.En Electronic Engineering Spa (2021) Summary page 4.

## 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

Source page: https://510kreport.com/device/K231309
Methodology: https://510kreport.com/methodology