# K023060: Acculaser PRO4

- Pathway: 510(k) (Traditional)
- Applicant: Acculaser, Inc.
- Decided: Mar 19, 2004 after 553 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020657: Acculaser Pro Low Level Laser Therapy Device, Acculaser, Inc. (2002) Summary page 1.
- K010175: Microlight 830 Laser System, Microlight Corporation of America (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K012580: Erchonia PL2000, Tuco Innovations, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K043353: Omega Excel/XP Laser System (2005), 1 descendant of its own
- K072551: LD-I 75 and LD-I 200 (2008), 0 descendants of its own

## Indications for use
The Acculaser T" Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.

Source page: https://510kreport.com/device/K023060
Methodology: https://510kreport.com/methodology