510(k) · Cleared
ClearedBiocare Systems Premir 818
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocare Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 13, 2004 as substantially equivalent to K022888 (Light Force Therapy, Inc., 2002) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1998. 8 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974468 (1998). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 1 generation backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- This deviceK042532 Biocare Systems Premir 818Biocare Systems, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK051816 Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc. · 2005 · Recalled
- Descendant · cites it directly · 3 of its ownK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK081570 DPL Therapy SystemLed Technologies, LLC · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK170068 Softcure 96Wellray Medical Laser, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK150554 NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K051816Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc. · 2005 · cites it directly3descendants
- K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005 · cites it directly3descendants
- K081570DPL Therapy SystemLed Technologies, LLC · 2008 · 2 generations on1descendant
- K170068Softcure 96Wellray Medical Laser, Inc. · 2017 · 2 generations on0descendants
- K150554NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −1 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| 0 (this device) | K042532 | Biocare Systems Premir 818 | Biocare Systems, Inc. | 2004 | — |
| +1 | K051816 | Lumiwave 1X4 Infrared Therapy Device | Biocare Systems, Inc. | 2005 | 1 |
| +1 | K051681 | Dermillume Red, Model HR1000 | Care Electronics, Inc. | 2005 | — |
| +2 | K081570 | DPL Therapy System | Led Technologies, LLC | 2008 | 1 |
| +2 | K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017 | — |
| +3 | K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K022888 | Acubeam, Super Nova, DioSummary page 1…PremIR 818 Infrared Therapy Device Classification name: Infrared Lamp PREDICATE DEVICES Trade name: LightForce Super Nova 51 0(k) number: K022888 and K001l179 Trade name: Quantum WARP 10 Light Delivery System 510(k) number: K032229 DEVICE DESCRIPTION The PremiR 818 isan o… | 2002 |
| * | K001179 | Super Nova, Acubeam | 2000 |
| * | K032229 | Quantum Warp 10 Light Delivery SystemSummary page 1…nfrared Lamp PREDICATE DEVICES Trade name: LightForce Super Nova 51 0(k) number: K022888 and K001l179 Trade name: Quantum WARP 10 Light Delivery System 510(k) number: K032229 DEVICE DESCRIPTION The PremiR 818 isan over-the-counter, infrared-therapy device, designed to emit energy at infrared frequenc… | 2003 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K051816 (Biocare Systems, Inc., 2005) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K022888.
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?
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief/ reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042532 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042532: Biocare Systems Premir 818.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042532
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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