# K871179: Opn Xii UL

- Pathway: 510(k) (Traditional)
- Applicant: Aragona AB Co.
- Decided: Apr 13, 1987 after 20 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.
323 later devices descend from it; 1 cites it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982636: Patient Warmer- Model PW810 (1998), 322 descendants of its own
- K022609: Surgical Patient Warmer, Model PW820 Jhu (2003), 295 descendants of its own
- K033768: Altus Medical Optional Infrared Handpiece (2004), 294 descendants of its own
- K042165: Cutera Tabletop Aesthetic Product (2004), 241 descendants of its own
- K050370: Palomar Luxir Handpiece (2005), 239 descendants of its own

Source page: https://510kreport.com/device/K871179
Methodology: https://510kreport.com/methodology