510(k) · Cleared
ClearedPhotosilk Plus Pulsed Light System and Laser Attachment
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 May 24, 2006 after a 356-day review. The FDA summary names its predicate without a number. 59 later devices descend from it.
- Decided
- May 24, 2006
- Review
- 356 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 2 citing it directly.
- This deviceK051442 Photosilk Plus Pulsed Light System and Laser AttachmentCynosure, Inc. · 2006
- Descendant · cites it directly · 38 of its ownK090235 Elite MPX Laser System with XPL HandpieceCynosure, Inc. · 2009
- Descendant · 2 generations on · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
- Descendant · 3 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016
- Descendant · 4 generations on · 30 of its ownK163222 Discovery Pico FamilyQuanta System Spa · 2016
- Descendant · 5 generations on · 21 of its ownK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K090235Elite MPX Laser System with XPL HandpieceCynosure, Inc. · 2009 · cites it directly38descendants
- K152012EVO platformQuanta System Spa · 2015 · 2 generations on37descendants
- K160368EVO platformQuanta System Spa · 2016 · 3 generations on36descendants
- K163222Discovery Pico FamilyQuanta System Spa · 2016 · 4 generations on30descendants
- K171945Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051442 | Photosilk Plus Pulsed Light System and Laser Attachment | Cynosure, Inc. | 2006 | — |
| +1 | K090235 | Elite MPX Laser System with XPL Handpiece | Cynosure, Inc. | 2009 | — |
| +2 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| +3 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| +4 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| +5 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | — | StarLux Pulsed Light System Named without a submission number | |
| * | — | C03 Er:YAG laser Named without a submission number | |
| * | — | ESC Nd:YAG Accessory Named without a submission number | |
| * | — | Medlite C6 Q-Switched Nd:YAG laser Named without a submission number |
What descends from it? (59)
See all 592 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?
- Of its descendants, K090235 (Cynosure, Inc., 2009) has gone furthest, with 38 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 PhotoSilk Plus Pulsed Light System is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The PhotoSilk Plus Pulsed Light System Laser Attachment is intended for:
Er:YAG 2,940 mn - for skin resurfacing and -for the incision, excision, ablation or vaporization of soft bodily tissues.
Long Pulse Nd:YAG 1,064 nm - for the treatment of vascular lesions, pigmented lesions, wrinkles and for permanent hair reduction..
0-Switched Nd:YAG 1,064 rim - for dark tattoo removal, and the treatment of pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051442: Photosilk Plus Pulsed Light System and Laser Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051442
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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