510(k) · Cleared
ClearedDermillume Red, Model HR1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Electronics, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 27, 2005 as substantially equivalent to K011355 (Biolight International AB, 2002) and 4 other predicates after a 34-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 27, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K943450 (1995). 96 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
- This deviceK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK081570 DPL Therapy SystemLed Technologies, LLC · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK150554 NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK070690 The Life VesselCottonwood Vessel Corporation · 2007
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
- This deviceK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K043575 | Dermillume, Model PRO1000 | Care Electronics, Inc. | 2005 | — |
| 0 (this device) | K051681 | Dermillume Red, Model HR1000 | Care Electronics, Inc. | 2005 | — |
| +1 | K081570 | DPL Therapy System | Led Technologies, LLC | 2008 | 1 |
| +2 | K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015 | — |
| +1 | K070690 | The Life Vessel | Cottonwood Vessel Corporation | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | K011355 | Biolight PCDSummary page 1…Infrared Therapy Lamp Classification: Lamp, Infrared; Class 11Product code: ILY Predicate Lamps: Biolight PCD (K01 1355), Biobeamn (K042813), Anodyne Therapy Systems (K931261), PremiR 818 (K042532),… | 2002 |
| * | K042813 | Biobeam Narrow Band Light Therapy DevicesSummary page 1…Infrared Therapy Lamp Classification: Lamp, Infrared; Class 11Product code: ILY Predicate Lamps: Biolight PCD (K01 1355), Biobeamn (K042813), Anodyne Therapy Systems (K931261), PremiR 818 (K042532),… | 2005 |
| * | K931261 | Spectropad SystemSummary page 1…ed; Class 11Product code: ILY Predicate Lamps: Biolight PCD (K01 1355), Biobeamn (K042813), Anodyne Therapy Systems (K931261), PremiR 818 (K042532), Dermillurne PrQ1000 (K(043575) Lamp Description: The… | 1994 |
| * | K042532 | Biocare Systems Premir 818Summary page 1…de: ILY Predicate Lamps: Biolight PCD (K01 1355), Biobeamn (K042813), Anodyne Therapy Systems (K931261), PremiR 818 (K042532), Dermillurne PrQ1000 (K(043575) Lamp Description: The Derrnillurne Red HR100… | 2004 |
| * | K043575 | Dermillume, Model PRO1000Summary page 1…Biobeamn (K042813), Anodyne Therapy Systems (K931261), PremiR 818 (K042532), Dermillurne PrQ1000 (K(043575) Lamp Description: The Derrnillurne Red HR1000 lamp is a compact light source… | 2005 |
What descends from it? (3)
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 10 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 96 ancestors have a recall of any class.
- Of its descendants, K081570 (Led Technologies, LLC, 2008) has gone furthest, with 1 descendant 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?
The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051681: Dermillume Red, Model HR1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051681
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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