# K082101: LS Family of CO2 Lasers with Scanning Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Nov 5, 2008 after 103 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.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040563: LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System (25 Watt), Sandstone Medical Technologies, LLC (2004) Summary page 1.

## Indications for use
Skin Resurfacing

Source page: https://510kreport.com/device/K082101
Methodology: https://510kreport.com/methodology