510(k) · Cleared
ClearedNanobeam 940, Model 940-900-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davaray, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 9, 2008 as substantially equivalent to K042813 (Life Without Pain, LLC, 2005) and 1 other predicate after a 347-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 9, 2008
- Review
- 347 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974468 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 3 generations backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- 2 generations backK042532 Biocare Systems Premir 818Biocare Systems, Inc. · 2004
- 1 generation backK051816 Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc. · 2005 · Recalled
- This deviceK073681 Nanobeam 940, Model 940-900-02Davaray, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −3 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| −2 | K042532 | Biocare Systems Premir 818 | Biocare Systems, Inc. | 2004 | — |
| −1 | K051816 | Lumiwave 1X4 Infrared Therapy Device | Biocare Systems, Inc. | 2005 | 1 |
| 0 (this device) | K073681 | Nanobeam 940, Model 940-900-02 | Davaray, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K042813 | Biobeam Narrow Band Light Therapy DevicesSummary page 1…4) 677-7791 Email: davidj arrndtgsbcglobal.net 2. Device Name Nanobearn 940 3. Predicate Device The Nanobeam 940 is similar to the BioBeam 940 (K0428 13), the MedLight 630 Pro (K042813) and the LumiWave I1X4 (KO51816). We consider the Nanobeam-940 to be substantially equi… | 2005 |
| * | K051816 | Lumiwave 1X4 Infrared Therapy Device | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K042813.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 indicated use of the Nanobeam 940 is to emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073681: Nanobeam 940, Model 940-900-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073681
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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