# K982546: Phaser-2000

- Pathway: 510(k) (Traditional)
- Applicant: Diomedics, Inc.
- Decided: Sep 22, 1998 after 63 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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.
480 later devices descend from it; 7 cite it directly.
0 of 481 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
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K032229: Quantum Warp 10 Light Delivery System (2003), 198 descendants of its own
- K043317: Omnilux Plus (2005), 171 descendants of its own
- K050216: Omnilux Revive and Omnilux Plus (2005), 160 descendants of its own

## Indications for use
The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

Source page: https://510kreport.com/device/K982546
Methodology: https://510kreport.com/methodology