510(k) · Cleared
ClearedSonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biorenew Labs, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Dec 30, 2015 as substantially equivalent to K121435 (Home Skinovations, Ltd., 2013) and 1 other predicate after a 91-day review. Its family tree reaches back 11 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 30, 2015
- Review
- 91 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K943450 (1995). 98 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 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 deviceK152889 Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC · 2015
- Descendant · cites it directly · 2 of its ownK170260 BC-001+ Acne PurifierOriental Inspiration Limited · 2017
- Descendant · 2 generations on · 1 of its ownK220729 The Luminance RED Acne DeviceLuminance Medical Ventures, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK251843 Erchonia EVRLErchonia Corporation · 2025
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 deviceK152889 Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC · 2015
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 |
|---|---|---|---|---|---|
| −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) | K152889 | Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus | Biorenew Labs, LLC | 2015 | — |
| +1 | K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | 2017 | — |
| +2 | K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | 2022 | — |
| +3 | K251843 | Erchonia EVRL | Erchonia Corporation | 2025 | — |
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 |
| 2022 | 1 | 0 |
| 2025 | 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 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 25.6 · 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? (2)
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 |
|---|---|---|---|
| * | K121435 | Silkn BlueSummary page 6…vice: These devices are substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: Primary Predicate Device: K121435 – Silk’n Blue (Home Skinovations LTD) Secondary Predicate Device: K124042 – Tanda Mini Skincare System (Syneron Beauty Inc… | 2013 |
| * | K124042 | Tanda Mini Skincare SystemSummary page 6…es, which are currently in safe and effective commerce: Primary Predicate Device: K121435 – Silk’n Blue (Home Skinovations LTD) Secondary Predicate Device: K124042 – Tanda Mini Skincare System (Syneron Beauty Inc.) Predicate Chart… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170260 | BC-001+ Acne Purifier | 2017 | 2 |
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 20 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, K170260 (Oriental Inspiration Limited, 2017) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K121435.
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. 2015, 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 Sonilase Blue is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in
the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the blue region of the light spectrum
for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light
spectrum for use in the treatment of mild to moderate acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152889: Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152889
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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