510(k) · Cleared
ClearedBiopack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioscan, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 18, 2000 after a 260-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Jul 18, 2000
- Review
- 260 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK993685 BiopackBioscan, Inc. · 2000
- Descendant · cites it directly · 22 of its ownK031612 Alt Laser, Model VTR 75Avicenna Laser Technology, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
- Descendant · 2 generations on · 8 of its ownK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
- Descendant · 2 generations on · 8 of its ownK052814 Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005
- Descendant · 3 generations on · 7 of its ownK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K031612Alt Laser, Model VTR 75Avicenna Laser Technology, Inc. · 2003 · cites it directly22descendants
- K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005 · 2 generations on12descendants
- K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007 · 2 generations on8descendants
- K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005 · 2 generations on8descendants
- K091497K-Laser K-1200, Model 12 WEltech S.R.L · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993685 | Biopack | Bioscan, Inc. | 2000 | — |
| +1 | K031612 | Alt Laser, Model VTR 75 | Avicenna Laser Technology, Inc. | 2003 | — |
| +2 | K050070 | K-Laser, Models 3,4,4D,6D | Eltech S.R.L | 2005 | — |
| +2 | K070400 | LC Therapy, Model LCT-1000 | Litecure, LLC | 2007 | — |
| +2 | K052814 | Lumina 1600, 3300 and 6600 Systems | Usa Laser Biotech, Inc. | 2005 | — |
| +3 | K091497 | K-Laser K-1200, Model 12 W | Eltech S.R.L | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 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? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031612 | Alt Laser, Model VTR 75 | 2003 | 22 |
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, K031612 (Avicenna Laser Technology, Inc., 2003) has gone furthest, with 22 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?
Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
Provides temporary relief of minor aches and pains in muscles and joints
Aids in the relaxation of muscles
Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
Provides a temporary increase in local blood circulation
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/K993685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993685: Biopack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993685
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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