510(k) · Cleared
ClearedPhaser-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diomedics, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Sep 22, 1998 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 480 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
480 later devices descend from it, 7 citing it directly.
- This deviceK982546 Phaser-2000Diomedics, Inc. · 1998
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 198 of its ownK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- Descendant · cites it directly · 171 of its ownK043317 Omnilux PlusPhoto Therapeutics Limited · 2005
- Descendant · 2 generations on · 160 of its ownK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
Showing 5 of 480 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 480 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003 · cites it directly198descendants
- K043317Omnilux PlusPhoto Therapeutics Limited · 2005 · cites it directly171descendants
- K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005 · 2 generations on160descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982546 | Phaser-2000 | Diomedics, Inc. | 1998 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| +1 | K043317 | Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| +2 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 11 | 0 |
| 2013 | 9 | 0 |
| 2014 | 14 | 0 |
| 2015 | 22 | 0 |
| 2016 | 21 | 0 |
| 2017 | 27 | 0 |
| 2018 | 20 | 0 |
| 2019 | 14 | 0 |
| 2020 | 26 | 0 |
| 2021 | 27 | 0 |
| 2022 | 37 | 0 |
| 2023 | 31 | 0 |
| 2024 | 49 | 0 |
| 2025 | 72 | 0 |
| 2026 | 47 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (480)
See all 4807 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K032229 | Quantum Warp 10 Light Delivery System | 2003 | 198 |
| K043317 | Omnilux Plus | 2005 | 171 |
| K042813 | Biobeam Narrow Band Light Therapy Devices | 2005 | 22 |
| K032787 | Neurolase, Models 150V, 150C, 1064 | 2003 | 15 |
| K112494 | Varaya AR , Varaya Sport | 2012 | 1 |
| K070690 | The Life Vessel | 2007 | 0 |
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, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 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 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982546: Phaser-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982546
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026