510(k) · Cleared
ClearedCynosure Photolight PL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 8, 2003 after a 78-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Jul 8, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK031258 Cynosure Photolight PLCynosure, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK082040 Minisilk FTEl.En Electronic Engineering Spa · 2009
- Descendant · 2 generations on · 18 of its ownK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- Descendant · 3 generations on · 17 of its ownK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- Descendant · 4 generations on · 16 of its ownK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- Descendant · 3 generations on · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K082040Minisilk FTEl.En Electronic Engineering Spa · 2009 · cites it directly19descendants
- K103288Deka Synchro FTEl.En Electronic Engineering Spa · 2011 · 2 generations on18descendants
- K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013 · 3 generations on17descendants
- K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015 · 4 generations on16descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031258 | Cynosure Photolight PL | Cynosure, Inc. | 2003 | — |
| +1 | K082040 | Minisilk FT | El.En Electronic Engineering Spa | 2009 | — |
| +2 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| +3 | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| +4 | K150516 | Deka Synchro Repla:Y Family of Laser Systems | El.En Electronic Engineering Spa | 2015 | — |
| +3 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | — | EsteLux pulsed light system Named without a submission number |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082040 | Minisilk FT | 2009 | 19 |
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?
- Of its descendants, K082040 (El.En Electronic Engineering Spa, 2009) has gone furthest, with 19 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Photolight Pulsed Light device is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031258: Cynosure Photolight PL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031258
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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