510(k) · Cleared
ClearedMinisilk FT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Aug 27, 2009 as substantially equivalent to K031258 (Cynosure, Inc., 2003) after a 405-day review. Its family tree reaches back 1 generation to 2003. 19 later devices descend from it.
- Decided
- Aug 27, 2009
- Review
- 405 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031258 (2003). 19 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK031258 Cynosure Photolight PLCynosure, Inc. · 2003
- This deviceK082040 Minisilk FTEl.En Electronic Engineering Spa · 2009
- Descendant · cites it directly · 18 of its ownK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- Descendant · 2 generations on · 17 of its ownK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- Descendant · 3 generations on · 16 of its ownK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- Descendant · 2 generations on · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- Descendant · 4 generations on · 2 of its ownK233090 DEKA AGAIN PRO familyEl.En S.P.A. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K103288Deka Synchro FTEl.En Electronic Engineering Spa · 2011 · cites it directly18descendants
- K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013 · 2 generations on17descendants
- K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015 · 3 generations on16descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · 2 generations on4descendants
- K233090DEKA AGAIN PRO familyEl.En S.P.A. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031258 | Cynosure Photolight PL | Cynosure, Inc. | 2003 | — |
| 0 (this device) | K082040 | Minisilk FT | El.En Electronic Engineering Spa | 2009 | — |
| +1 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| +2 | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| +3 | K150516 | Deka Synchro Repla:Y Family of Laser Systems | El.En Electronic Engineering Spa | 2015 | — |
| +2 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
| +4 | K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 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 |
|---|---|---|---|
| * | K031258 | Cynosure Photolight PLSummary page 1…nt with thermal effect ONF 21 CFR 878.4810 Equivalent Devices: Cynosure Photolight PL - K03 1258 Device Description: The Minisilk-FT is a pulsed light system having a Xenon flashlamp… | 2003 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103288 | Deka Synchro FT | 2011 | 18 |
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?
- Its one ancestor has no recall.
- Of its descendants, K103288 (El.En Electronic Engineering Spa, 2011) has gone furthest, with 18 descendants of its own.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MinisilkFT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082040: Minisilk FT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082040
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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