# K043353: Omega Excel/XP Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Technologies, Inc.
- Decided: Jul 1, 2005 after 207 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: 4 generations back to K001179 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023060: Acculaser PRO4, Acculaser, Inc. (2004) Summary page 2.
- K041530: Excalibur Light Therapy System, Model Sgiex-04-001, Stargate International, Inc. (2004) Summary page 2.

## Most influential descendants
- K072551: LD-I 75 and LD-I 200 (2008), 0 descendants of its own

## Indications for use
The Omega Xp Laser System is intended for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

Source page: https://510kreport.com/device/K043353
Methodology: https://510kreport.com/methodology