510(k) · Cleared
ClearedAklarus Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 16, 2009 as substantially equivalent to K060792 (Photoactif, LLC, 2006) and 4 other predicates after a 261-day review. Its family tree reaches back 11 generations to 1995. 91 later devices descend from it.
- Decided
- Jul 16, 2009
- Review
- 261 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K943450 (1995). 131 ancestors in all, the oldest K800617 (1980). 91 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 1 generation backK060792 IllumimedPhotoactif, LLC · 2006
- This deviceK083183 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 · 3 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · cites it directly · 49 of its ownK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- Descendant · 2 generations on · 46 of its ownK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 1 generation backK060792 IllumimedPhotoactif, LLC · 2006
- This deviceK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K111286Quasar CalypsoSilver Bay, LLC · 2012 · cites it directly76descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 2 generations on75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 3 generations on58descendants
- K152280BioPhotas Celluma3Biophotas, Inc. · 2016 · cites it directly49descendants
- K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd. · 2021 · 2 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −1 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| 0 (this device) | 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 | — |
| +3 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +1 | K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016 | — |
| +2 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons… | Ningbo Hesi Electric Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 34 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K060792 | IllumimedSummary page 2…or Model Name or Model Manufacturer Class K060792 Illumimed Hill Laboratories 2 12. Additional Predicates 1 K050216… | 2006 |
| * | K050216 | Omnilux Revive and Omnilux PlusSummary page 2…Manufacturer Class K060792 Illumimed Hill Laboratories 2 12. Additional Predicates 1 K050216 1 Omnilux mlus Revive Reviv & Omn… | 2005 |
| * | K041103 | AcneliftSummary page 2…mlus Revive Reviv & Omnilux 1 Photo Therapeutics Limited Plus Combo 2 K041103 2 AcneLift 2 Inner Act, LLC Aklarus Phototherapy System 510(k)… | 2004 |
| * | K030883 | Omnilux BlueSummary page 3…ift 2 Inner Act, LLC Aklarus Phototherapy System 510(k) September 6, 2008 Section 5-2 3 K030883 3 Omnnilux Blue 3 Photo Therapeutics Limited 4 K043317 4 Om… | 2003 |
| * | K043317 | Omnilux PlusSummary page 3…eptember 6, 2008 Section 5-2 3 K030883 3 Omnnilux Blue 3 Photo Therapeutics Limited 4 K043317 4 Omnilux Plus 4 Photo Therapeutics Limited 13. 'Conclusion The pro… | 2005 |
What descends from it? (91)
See all 914 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 14 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 131 ancestors have a recall of any class.
- Of its descendants, K111286 (Silver Bay, LLC, 2012) has gone furthest, with 76 descendants of its own.
- 4 other devices also cite its predicate K060792.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Aklarus Blue (420nm +/-1Onm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Aklarus combination of Red (628nm +/-10rm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat. mild to moderate acne vulgaris. The Aklarus Anti-Aging Red (628nm +/-lOnm) and…
Read the full statement (150 words)
The Aklarus Blue (420nm +/-1Onm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Aklarus combination of Red (628nm +/-10rm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat. mild to moderate acne vulgaris.
The Aklarus Anti-Aging Red (628nm +/-lOnm) and Anti-Aging Infrared (880nm +/-10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Aklarus Infrared (880nm +/-1Onm) is intended to emit energy 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 local blood circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083183: Aklarus Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083183
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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