# K012580: Erchonia PL2000

- Pathway: 510(k) (Traditional)
- Applicant: Tuco Innovations, Inc.
- Decided: Jan 17, 2002 after 161 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
No predicates in its family tree.
77 later devices descend from it; 5 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032816: Quantum Light Therapy System (2004), 73 descendants of its own
- K091496: Mep-90 Hair Growth Stimulation System (2010), 58 descendants of its own
- K113097: Laser Helmet (2012), 57 descendants of its own
- K150613: LaserCap LC Pro and LC Elite (2015), 46 descendants of its own
- K122950: Laser Helmet (2013), 46 descendants of its own

## Indications for use
The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary refief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K012580
Methodology: https://510kreport.com/methodology