510(k) · Cleared
ClearedSilk'n FX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 19, 2011 as substantially equivalent to K072459 (Photo Therapeutics, Inc., 2008) after a 198-day review. Its family tree reaches back 11 generations to 1995. 66 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K943450 (1995). 91 ancestors in all, the oldest K800617 (1980). 66 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 backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 1 generation backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- This deviceK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- Descendant · cites it directly · 61 of its ownK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- Descendant · 2 generations on · 55 of its ownK162489 RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017
- Descendant · 3 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 3 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 4 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
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 backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 1 generation backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- This deviceK110301 Silk'n FXHome Skinovations, Ltd. · 2011
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016 · cites it directly61descendants
- K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017 · 2 generations on55descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 3 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 3 generations on39descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 4 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 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −1 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| 0 (this device) | K110301 | Silk'n FX | Home Skinovations, Ltd. | 2011 | — |
| +1 | K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016 | — |
| +2 | K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017 | — |
| +3 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +3 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +4 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 30 | 0 |
| 2026 | 15 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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 |
|---|---|---|---|
| * | K072459 | Omnilux New-USummary page 1…general and plastic surgery and in dermatology (2J1CRF §878.48 10) Product code: OHS Predicate device * Omilux New-U, (K072459), By Photo Therapeutics Inc. Intended use: Silkn FX is an over the counter device indicated to emit energy in the red and JR r… | 2008 |
What descends from it? (66)
See all 664 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 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 91 ancestors have a recall of any class.
- Of its descendants, K152332 (Omm Imports Inc Dba Zero Gravity, 2016) has gone furthest, with 61 descendants of its own.
- 5 other devices also cite its predicate K072459.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
Silkn FX is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110301: Silk'n FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110301
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