# K033015: Axiom Biolaser LLLT Series-3

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Usa., Inc.
- Decided: Nov 25, 2003 after 60 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: 2 generations back to K010175 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030692: Power Laser 90, Andi Electromedical Aps (2003)
- K010175: Microlight 830 Laser System, Microlight Corporation of America (2002)

## Indications for use
The Axiom BioLaser LLLT Series-3 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/K033015
Methodology: https://510kreport.com/methodology