510(k) · Cleared
Recalled · Class II · 2012Painacea Model XR8 Infrared Heat Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantis Luminescent Products, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 10, 2005 as substantially equivalent to K024027 (Skytech Enterprises, Inc., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1988. It has been recalled 3 times.
- Decided
- May 10, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- ILY
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K875052 (1988). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 2 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 1 generation backK024027 Lightwave Infrared Lamps LW10D and LW30DSkytech Enterprises, Inc. · 2003
- This deviceK051046 Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −2 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −1 | K024027 | Lightwave Infrared Lamps LW10D and LW30D | Skytech Enterprises, Inc. | 2003 | — |
| 0 (this device) | K051046 | Painacea Model XR8 Infrared Heat Lamp | Atlantis Luminescent Products, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024027 | Lightwave Infrared Lamps LW10D and LW30DSummary page 1…ce: The Painacea Mode! XR8 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Light Wave (K024027) and Warp 10 (K032229). 3. Intended use ot the Device: The Painacea Model XR8 infrare… | 2003 |
| * | K032229 | Quantum Warp 10 Light Delivery SystemSummary page 1…! XR8 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Light Wave (K024027) and Warp 10 (K032229). 3. Intended use ot the Device: The Painacea Model XR8 infrared heat lamp is intended to emit energy… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2012 | Class II | Z-0517-2013 | No Marketing Application | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. |
| Oct 25, 2012 | Class II | Z-0518-2013 | No Marketing Application | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. |
| Oct 25, 2012 | Class II | Z-0519-2013 | No Marketing Application | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 12 ancestors has a recall.
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 Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051046: Painacea Model XR8 Infrared Heat Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051046
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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