# K980538: Laser Lancet LB100

- Pathway: 510(k) (Traditional)
- Applicant: Transmedica Intl., Inc.
- Decided: Jul 9, 1998 after 148 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 K955653 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955653: Venisect Laser Lancet, Venisect, Inc. (1997) Summary page 1.

## Most influential descendants
- K021222: Lad, Model Lad-01 (2003), 1 descendant of its own
- K040525: Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000 (2004), 0 descendants of its own

## Indications for use
The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.

Source page: https://510kreport.com/device/K980538
Methodology: https://510kreport.com/methodology