510(k) · Cleared
ClearedSilkn Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Feb 22, 2013 as substantially equivalent to K060653 (Dermacare, Inc., 2006) and 3 other predicates after a 284-day review. Its family tree reaches back 10 generations to 1995. 125 later devices descend from it.
- Decided
- Feb 22, 2013
- Review
- 284 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K943450 (1995). 96 ancestors in all, the oldest K800617 (1980). 125 later devices descend from it, 8 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 deviceK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · cites it directly · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · cites it directly · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 2 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 2 generations on · 55 of its ownK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- Descendant · cites it directly · 52 of its ownK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- This deviceK121435 Silkn BlueHome Skinovations, Ltd. · 2013
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · cites it directly81descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · cites it directly75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 2 generations on58descendants
- K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015 · 2 generations on55descendants
- K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018 · cites it directly52descendants
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) | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +1 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +1 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +2 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +2 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
| +1 | K172555 | Sapphire, Elevare Sapphire | Omm Imports, Inc. D/B/A Zero Gravity | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 41 | 0 |
| 2026 | 20 | 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? (4)
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 |
|---|---|---|---|
| * | K060653 | ThermaclearSummary page 1…wered light based laser for Acne, 21 CFR 878.4810 Product code: OLP Predicate devices * ThermaClearby DermaCarelInc. K060653. * Quasar Blue Light Therapy System by Silver Bay LLC, K093963. * Tanda Skincare System, by Pharos Life Corporation,… | 2006 |
| * | K093963 | Quasar Blue Light Therapy SystemSummary page 1…R 878.4810 Product code: OLP Predicate devices * ThermaClearby DermaCarelInc. K060653. * Quasar Blue Light Therapy System by Silver Bay LLC, K093963. * Tanda Skincare System, by Pharos Life Corporation, K080591 * Omni Lux New-U, by Photo Therapeutics Inc, K08 13 07.… | 2010 |
| * | K080591 | Tanda Skincare System, Model: PtscsSummary page 1…ThermaClearby DermaCarelInc. K060653. * Quasar Blue Light Therapy System by Silver Bay LLC, K093963. * Tanda Skincare System, by Pharos Life Corporation, K080591 * Omni Lux New-U, by Photo Therapeutics Inc, K08 13 07. Intended use: The Silkn Blue is indicated as an over the counter… | 2008 |
| * | K081307 | Omnilux Clear-USummary page 1…ue Light Therapy System by Silver Bay LLC, K093963. * Tanda Skincare System, by Pharos Life Corporation, K080591 * Omni Lux New-U, by Photo Therapeutics Inc, K08 13 07. Intended use: The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate ac… | 2009 |
What descends from it? (125)
See all 1258 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131461 | Lightstim for Acne/ Lightstim for Acne Mini | 2014 | 81 |
| K162098 | LED Phototherapy Device | 2017 | 75 |
| K172555 | Sapphire, Elevare Sapphire | 2018 | 52 |
| K153081 | Clear Bi-Light | 2016 | 46 |
| K180320 | dpl IIa Panel | 2018 | 14 |
| K162652 | Smart Photon Micro-current Device, Model: EP-300 | 2017 | 10 |
| K152889 | Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus | 2015 | 3 |
| K143713 | Lustre PRO Light System | 2016 | 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 18 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 96 ancestors have a recall of any class.
- Of its descendants, K131461 (Led Intellectual Properties, LLC, 2014) has gone furthest, with 81 descendants of its own.
- 4 other devices also cite its predicate K060653.
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 Silkn Blue is indicated as an over the counter phototherapy device for the
treatment of mild to moderate acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121435: Silkn Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121435
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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