510(k) · Cleared
ClearedBiolight PCD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolight International AB · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 17, 2002 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 259 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK011355 Biolight PCDBiolight International AB · 2002
- 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 · 3 generations on · 0 of its ownK150554 NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK070690 The Life VesselCottonwood Vessel Corporation · 2007
Most influential descendants
Showing 4 of 4 · See all- K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005 · cites it directly3descendants
- K081570DPL Therapy SystemLed Technologies, LLC · 2008 · 2 generations on1descendant
- K150554NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015 · 3 generations on0descendants
- K070690The Life VesselCottonwood Vessel Corporation · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011355 | Biolight PCD | Biolight International AB | 2002 | — |
| +1 | K051681 | Dermillume Red, Model HR1000 | Care Electronics, Inc. | 2005 | — |
| +2 | K081570 | DPL Therapy System | Led Technologies, LLC | 2008 | 1 |
| +3 | K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015 | — |
| +2 | K070690 | The Life Vessel | Cottonwood Vessel Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051681 | Dermillume Red, Model HR1000 | 2005 | 3 |
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, K051681 (Care Electronics, Inc., 2005) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K011355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011355: Biolight PCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011355
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026