# K013021: Lightlance Laser Skin Perforator

- Pathway: 510(k) (Traditional)
- Applicant: Innotech USA, Inc.
- Decided: May 30, 2002 after 265 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: 1 generation back to K981746 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983673: Lasette, Cell Robotics, Inc. (1999) Summary page 2.
- K981746: Cell Robotics' Lasette, Cell Robotics, Inc. (1998) Summary page 2.

## Most influential descendants
- K172818: LMT-3000 (2018), 1 descendant of its own
- K241646: Ortiv (Ortiv-BL, Ortiv-WH) (2024), 0 descendants of its own

## Indications for use
The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings

Source page: https://510kreport.com/device/K013021
Methodology: https://510kreport.com/methodology