510(k) · Cleared
ClearedIllumimed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photoactif, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 1, 2006 as substantially equivalent to K050216 (Photo Therapeutics Limited, 2005) and 5 other predicates after a 253-day review. Its family tree reaches back 10 generations to 1995. 115 later devices descend from it.
- Decided
- Dec 1, 2006
- Review
- 253 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K943450 (1995). 130 ancestors in all, the oldest K800617 (1980). 115 later devices descend from it, 5 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 backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- This deviceK060792 IllumimedPhotoactif, LLC · 2006
- Descendant · cites it directly · 91 of its ownK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- Descendant · cites it directly · 76 of its ownK111286 Quasar CalypsoSilver Bay, LLC · 2012
- Descendant · 2 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · cites it directly · 71 of its ownK122237 Biophotas LifelightBiophotas, Inc. · 2013
- Descendant · 3 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
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 backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- This deviceK060792 IllumimedPhotoactif, LLC · 2006
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K083183Aklarus Phototherapy SystemHill Laboratories Co. · 2009 · cites it directly91descendants
- K111286Quasar CalypsoSilver Bay, LLC · 2012 · cites it directly76descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 2 generations on75descendants
- K122237Biophotas LifelightBiophotas, Inc. · 2013 · cites it directly71descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 3 generations on58descendants
View 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 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| 0 (this device) | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| +1 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| +1 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| +2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +1 | K122237 | Biophotas Lifelight | Biophotas, Inc. | 2013 | — |
| +3 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 38 | 0 |
| 2026 | 22 | 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? (6)
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 |
|---|---|---|---|
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 1…ibit 13. The identified legally marketed GEX predicate devices identified by the submitter are: * Omnilux Revive and Omnilux Plus Combination, K050216, from Photo Therapeutics Limited, Cheshire, United Kingdom * Omnilux Blue, K030883, from Photo Therapeu… | 2005 |
| * | K030883 | Omnilux BlueSummary page 1…: * Omnilux Revive and Omnilux Plus Combination, K050216, from Photo Therapeutics Limited, Cheshire, United Kingdom * Omnilux Blue, K030883, from Photo Therapeutics Limited, Cheshire, United Kingdom * RevLight®, Skincare System, K042630, from… | 2003 |
| * | K042630 | Revlight Skin Care SystemSummary page 1…re, United Kingdom * Omnilux Blue, K030883, from Photo Therapeutics Limited, Cheshire, United Kingdom * RevLight®, Skincare System, K042630, from Skincare Technology Inc., Chicago, IL * AcneLift, K041103, from Inner Act LLC, Reno, Nevada.… | 2005 |
| * | K041103 | AcneliftSummary page 1…heshire, United Kingdom * RevLight®, Skincare System, K042630, from Skincare Technology Inc., Chicago, IL * AcneLift, K041103, from Inner Act LLC, Reno, Nevada. One legally marketed ILY predicate device is: * Omnilux Plus, K043317, from… | 2004 |
| * | K043317 | Omnilux PlusSummary page 1…Chicago, IL * AcneLift, K041103, from Inner Act LLC, Reno, Nevada. One legally marketed ILY predicate device is: * Omnilux Plus, K043317, from Photo Therapeutics Limited, Cheshire, United Kingdom.… | 2005 |
| * | K030426 | Omnilux RedSummary page 8…Plus Combination [K050216], Omnilux Blue [K030883], RevLight, Skincare System [K042630], and AcneL-ift [K041 103]; and the ILY predicate Ornnilux Revive [K030426]. The submitter's claim the submitted device is safe and effective for its intended use as both a prescription and non… | 2003 |
What descends from it? (115)
See all 1155 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 11 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 130 ancestors have a recall of any class.
- Of its descendants, K083183 (Hill Laboratories Co., 2009) has gone furthest, with 91 descendants of its own.
- 5 other devices also cite its predicate K050216.
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 of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving…
Read the full statement (265 words)
Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the accessory "38 red/near infrared LED Wand", 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "240 red/near infrared LED Pad", 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060792: Illumimed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060792
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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