# K021222: Lad, Model Lad-01

- Pathway: 510(k) (Traditional)
- Applicant: Norwood Abbey, Ltd.
- Decided: Jan 8, 2003 after 266 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: 2 generations back to K934335 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974855: Phoresor II, Model PM900, Iomed, Inc. (1998) Summary page 1.
- K980538: Laser Lancet LB100, Transmedica Intl., Inc. (1998) Summary page 1.

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

## Indications for use
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

Source page: https://510kreport.com/device/K021222
Methodology: https://510kreport.com/methodology