510(k) · Cleared
ClearedPhotosilk Pulsed Light System
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 26, 2004 after a 29-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 26, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK041095 Photosilk Pulsed Light SystemCynosure, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- Descendant · 2 generations on · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 4 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 5 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051508Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005 · cites it directly8descendants
- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · 2 generations on6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 3 generations on4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 4 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041095 | Photosilk Pulsed Light System | Cynosure, Inc. | 2004 | — |
| +1 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| +2 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +3 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +4 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +5 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | Photolight PL system Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051508 | Med Flash II Intense Pulsed Light System. | 2005 | 8 |
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, K051508 (General Project S.R.L., 2005) has gone furthest, with 8 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 and Photosilk Plus pulsed light system 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 integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to redace patient pain and discomfort associated with light applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041095 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041095: Photosilk Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041095
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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