# K980131: Alex TA2 Eraser

- Pathway: 510(k) (Traditional)
- Applicant: Light Age, Inc.
- Decided: Feb 17, 1998 after 33 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 K950684 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935631: Conbio Medalex Laser System, Continuum Biomedical, Inc. (1994) Summary page 1.
- K961006: Medlite/755 Alexandrite Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.

## Indications for use
Removal of dark and light ink tattoos and the removal of pigmented lesions.

Source page: https://510kreport.com/device/K980131
Methodology: https://510kreport.com/methodology