# K034009: LAPEX 2000

- Pathway: 510(k) (Abbreviated)
- Applicant: Meridian Co., Ltd.
- Decided: Jan 21, 2005 after 394 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010175 (2002). 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)
- K030226: Thor Ddii 830CL3 Laser System, Thor Intl. (2003) Summary page 1.
- K010175: Microlight 830 Laser System, Microlight Corporation of America (2002) Summary page 1.

## Most influential descendants
- K063574: Luminex LL Laser System (2007), 0 descendants of its own

## Indications for use
The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Source page: https://510kreport.com/device/K034009
Methodology: https://510kreport.com/methodology
