510(k) · Cleared
ClearedIllumask Acne Light Therapy Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
La Lumiere, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Aug 28, 2013 as substantially equivalent to K081307 (Photo Therapeutics, Inc., 2009) after a 245-day review. Its family tree reaches back 10 generations to 1995. 112 later devices descend from it.
- Decided
- Aug 28, 2013
- Review
- 245 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K943450 (1995). 87 ancestors in all, the oldest K800617 (1980). 112 later devices descend from it, 3 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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- This deviceK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- Descendant · cites it directly · 107 of its ownK140471 Pro X Otc 5La Lumiere, LLC · 2015
- Descendant · 2 generations on · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- Descendant · 3 generations on · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
- Descendant · 4 generations on · 71 of its ownK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- Descendant · 2 generations on · 56 of its ownK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- This deviceK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K140471Pro X Otc 5La Lumiere, LLC · 2015 · cites it directly107descendants
- K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · 2 generations on106descendants
- K170984LG Beauty Led MaskLg Electronics · 2017 · 3 generations on93descendants
- K191629faceLITEIsmart Marketing Svcs, Ltd. · 2019 · 4 generations on71descendants
- K171323Biophotas CELLUMA3Biophotas, Inc. · 2017 · 2 generations on56descendants
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 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| 0 (this device) | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| +1 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| +2 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| +3 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| +4 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| +2 | K171323 | Biophotas CELLUMA3 | Biophotas, Inc. | 2017 | — |
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 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 43 | 0 |
| 2026 | 21 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K081307 | Omnilux Clear-USummary page 1…Code: OLP Device Class: 11 4. Predicate Device Omnilux Clear-U Acne Treatment System. Manufactured by PhotoTherapeutics, Ltd. Montgomeryville, PA 18936. K08 1307. 5. Device Description The IlluMask Acne Light Therapy device uses known LED light therapy technology for the treatment of mild… | 2009 |
What descends from it? (112)
See all 1123 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 18 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 87 ancestors have a recall of any class.
- Of its descendants, K140471 (La Lumiere, LLC, 2015) has gone furthest, with 107 descendants of its own.
- 8 other devices also cite its predicate K081307.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The illuMask Acne Light Therapy Mask is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123999: Illumask Acne Light Therapy Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123999
Report an extraction error
Are you the manufacturer?
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