510(k) · Cleared
ClearedModification to Ifl Professional System, Model C100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyden Limited · GEX Powered Laser Surgical Instrument
Cleared on Apr 19, 2005 as substantially equivalent to K040081 (Palomar Medical Technologies, Inc., 2004) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.
- Decided
- Apr 19, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000811 (2000). 5 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
- 2 generations backK013461 Nlite System,Model A00-1025Icn Photonics, Ltd. · 2002
- 1 generation backK024189 Nlite System, Model#: A00-1025/A00-1033Icn Photonics, Ltd. · 2003
- This deviceK050165 Modification to Ifl Professional System, Model C100Cyden Limited · 2005
- Descendant · cites it directly · 8 of its ownK060234 Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006
- 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 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006 · 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 |
|---|---|---|---|---|---|
| −3 | K000811 | Nlite System, SLS Model Number A00-1025 | Sls Biophile, Ltd. | 2000 | — |
| −2 | K013461 | Nlite System,Model A00-1025 | Icn Photonics, Ltd. | 2002 | — |
| −1 | K024189 | Nlite System, Model#: A00-1025/A00-1033 | Icn Photonics, Ltd. | 2003 | — |
| 0 (this device) | K050165 | Modification to Ifl Professional System, Model C100 | Cyden Limited | 2005 | — |
| +1 | K060234 | Mccue Energist Ultra VPL Intense Pulse Light System | Mccue Plc | 2006 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K040081 | Palomar Luxv HandpieceSummary page 1…on Name: Laser Powered Surgical Instrument 3. Predicate Devices * Palomar Estelux System, LuxV Handpiece cleared April 2004, 510(k) approval number K040081; * Radiancy Acne System with ClearTouch cleared December 2003, 510(k) approval number K032205; * ICN NLite… | 2004 |
| * | K032205 | Radiancy Acne System with Cleartouch Light Unit AssemblySummary page 1…ndpiece cleared April 2004, 510(k) approval number K040081; * Radiancy Acne System with ClearTouch cleared December 2003, 510(k) approval number K032205; * ICN NLite System, cleared June 2003, 510(k) approval number K024189. 4. Product Description The IFL Profes… | 2003 |
| * | K024189 | Nlite System, Model#: A00-1025/A00-1033Summary page 1…Acne System with ClearTouch cleared December 2003, 510(k) approval number K032205; * ICN NLite System, cleared June 2003, 510(k) approval number K024189. 4. Product Description The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavel… | 2003 |
What descends from it? (10)
3 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 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K060234 (Mccue Plc, 2006) has gone furthest, with 8 descendants of its own.
- 9 other devices also cite its predicate K040081.
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 IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.
In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.
The IFL Professional is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050165: Modification to Ifl Professional System, Model C100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050165
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