# K080513: Qlaser System

- Pathway: 510(k) (Traditional)
- Applicant: 2035, Inc.
- Decided: Jan 30, 2009 after 340 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K100116: Lasertouchone (Otc) (2010), 0 descendants of its own

## Indications for use
The QLaser System is indicated for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed' by a physician or other licensed medical professional.

Source page: https://510kreport.com/device/K080513
Methodology: https://510kreport.com/methodology