510(k) · Cleared
ClearedOpn Xii UL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aragona AB Co. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Apr 13, 1987 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 323 later devices descend from it.
- Decided
- Apr 13, 1987
- Review
- 20 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
323 later devices descend from it, 1 citing it directly.
- This deviceK871179 Opn Xii ULAragona AB Co. · 1987
- Descendant · cites it directly · 322 of its ownK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- Descendant · 2 generations on · 295 of its ownK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- Descendant · 3 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 4 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
Showing 5 of 323 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 323 · See all- K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998 · cites it directly322descendants
- K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003 · 2 generations on295descendants
- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 3 generations on294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 4 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 4 generations on239descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| +1 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| +2 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +3 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +4 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +4 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 28 | 0 |
| 2021 | 22 | 0 |
| 2022 | 31 | 0 |
| 2023 | 21 | 0 |
| 2024 | 30 | 0 |
| 2025 | 38 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (323)
See all 3231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982636 | Patient Warmer- Model PW810 | 1998 | 322 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982636 (Fisher & Paykel Healthcare, Ltd., 1998) has gone furthest, with 322 descendants of its own.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K871179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K871179: Opn Xii UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871179
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026