# K963340: Medlite ND:Yag Laser System: New Dye Accessory Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: May 12, 1997 after 259 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 K915497 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955131: Medlite Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K952636: Medlite Laser System, Continuum Biomedical, Inc. (1995) Summary page 1.
- K940607: Conbio Medlite Q-Switched ND:Yag Laser System, Continuum Biomedical, Inc. (1994) Summary page 1.
- K940636: Conbio Medlite Q-Switched ND:Yag Laser System, Continuum Biomedical, Inc. (1994) Summary page 1.
- K922935: Conbio-Medlite Q-Switched ND:Yag Laser System, Buckman Co., Inc. (1993) Summary page 1.
- K922577: Conbio-Medlite (TM) Q-Switched ND:Yag Laser System, Continuum Biomedical, Inc. (1993) Summary page 1.
- K915497: Conbio Medlite Q-Switched ND:Yag Laser System, Continuum Biomedical, Inc. (1992) Summary page 1.

## Indications for use
For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.

Source page: https://510kreport.com/device/K963340
Methodology: https://510kreport.com/methodology