510(k) · Cleared
ClearedMB System, Bioenergy Light Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amest Corp. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Nov 29, 2004 as substantially equivalent to K020017 (Medx Electronics, Inc., 2002) and 1 other predicate after a 672-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 29, 2004
- Review
- 672 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001179 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| 0 (this device) | K030275 | MB System, Bioenergy Light Therapy | Amest Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K020017 | Medx 1000 SeriesSummary page 1…Light Therapy Systemn Classification: Infrared lamp (21 CFR 890.5500) Product Code: ILY 3. Substantially Equivalent Devices 1. K.020017 - MedX Health Corp. MedX 1000 Series Infrared Lamp 2. 1-014208 Russian American Technology Associates, Inc., S… | 2002 |
| * | K014208 | Ssir SystemSummary page 1…amp (21 CFR 890.5500) Product Code: ILY 3. Substantially Equivalent Devices 1. K.020017 - MedX Health Corp. MedX 1000 Series Infrared Lamp 2. 1-014208 Russian American Technology Associates, Inc., SSIR Tamp 4. Device Description: The MB RioEnergy Liglt Therapy System… | 2002 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- 7 other devices also cite its predicate K020017.
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 MB System is a device that emits energy in the infrared spectrum to provide
temporary increase in local blood circulation, temporary relief of muscle pain, spasms
and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and
relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030275: MB System, Bioenergy Light Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030275
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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