510(k) · Cleared
ClearedClear Bi-Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michael Todd, LP · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Feb 15, 2016 as substantially equivalent to K124042 (Syneron Beauty, 2013) and 2 other predicates after a 115-day review. Its family tree reaches back 11 generations to 1995. 46 later devices descend from it.
- Decided
- Feb 15, 2016
- Review
- 115 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K943450 (1995). 98 ancestors in all, the oldest K800617 (1980). 46 later devices descend from it, 3 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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK153081 Clear Bi-LightMichael Todd, LP · 2016
- Descendant · cites it directly · 35 of its ownK180447 reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
- Descendant · cites it directly · 29 of its ownK180900 LED Light Therapy DeviceUvbiotek, LLC · 2018
- Descendant · 2 generations on · 22 of its ownK183708 Poly ClearMedtek Skincare, LLC · 2019
- Descendant · 2 generations on · 22 of its ownK183118 dpl SpotLiteLed Technologies, Inc. · 2019
- Descendant · 2 generations on · 21 of its ownK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical 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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK153081 Clear Bi-LightMichael Todd, LP · 2016
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018 · cites it directly35descendants
- K180900LED Light Therapy DeviceUvbiotek, LLC · 2018 · cites it directly29descendants
- K183708Poly ClearMedtek Skincare, LLC · 2019 · 2 generations on22descendants
- K183118dpl SpotLiteLed Technologies, Inc. · 2019 · 2 generations on22descendants
- K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021 · 2 generations on21descendants
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 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| 0 (this device) | K153081 | Clear Bi-Light | Michael Todd, LP | 2016 | — |
| +1 | K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2018 | — |
| +1 | K180900 | LED Light Therapy Device | Uvbiotek, LLC | 2018 | — |
| +2 | K183708 | Poly Clear | Medtek Skincare, LLC | 2019 | — |
| +2 | K183118 | dpl SpotLite | Led Technologies, Inc. | 2019 | — |
| +2 | K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
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 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 19 | 0 |
| 2026 | 8 | 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? (3)
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 |
|---|---|---|---|
| * | K124042 | Tanda Mini Skincare SystemSummary page 4…Review Panel: General and Plastic Surgery Devices Class: II E. Predicate Device: Tanda Mini Skincare System, K124042 Silkn Blue, K121435 OmniLux Clear U, K081307 Michael Todd, LP Cle… | 2013 |
| * | K121435 | Silkn BlueSummary page 4…stic Surgery Devices Class: II E. Predicate Device: Tanda Mini Skincare System, K124042 Silkn Blue, K121435 OmniLux Clear U, K081307 Michael Todd, LP Clear Bi-Light 510(k) Section 8: 510(… | 2013 |
| * | K081307 | Omnilux Clear-USummary page 4…II E. Predicate Device: Tanda Mini Skincare System, K124042 Silkn Blue, K121435 OmniLux Clear U, K081307 Michael Todd, LP Clear Bi-Light 510(k) Section 8: 510(k) Summary… | 2009 |
What descends from it? (46)
See all 463 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 21 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 98 ancestors have a recall of any class.
- Of its descendants, K180447 (Led Technologies, Inc., 2018) has gone furthest, with 35 descendants of its own.
- 6 other devices also cite its predicate K124042.
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. 2016, 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 Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153081: Clear Bi-Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153081
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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