# K211362: SCAR 3

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Aug 25, 2021 after 114 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: 7 generations back to K936109 (1994). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151331: The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch, Lumenis, Ltd. (2015) Summary page 4.

## Most influential descendants
- K231309: SCAR 3 (2023), 0 descendants of its own

## 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 (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

Source page: https://510kreport.com/device/K211362
Methodology: https://510kreport.com/methodology