510(k) · Cleared
ClearedNlite System, Model#: A00-1025/A00-1033
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icn Photonics, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 20, 2003 as substantially equivalent to K000811 (Sls Biophile, Ltd., 2000) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 2000. 328 later devices descend from it.
- Decided
- Jun 20, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000811 (2000). 328 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
- 1 generation backK013461 Nlite System,Model A00-1025Icn Photonics, Ltd. · 2002
- This deviceK024189 Nlite System, Model#: A00-1025/A00-1033Icn Photonics, Ltd. · 2003
- Descendant · cites it directly · 316 of its ownK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
- Descendant · cites it directly · 230 of its ownK033331 Candela Cbeam Pulse Dye Laser SystemCandela Corp. · 2004
- Descendant · 2 generations on · 205 of its ownK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 3 generations on · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
Showing 5 of 328 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 328 · See all- K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004 · cites it directly316descendants
- K033331Candela Cbeam Pulse Dye Laser SystemCandela Corp. · 2004 · cites it directly230descendants
- K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · 2 generations on205descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 3 generations on195descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000811 | Nlite System, SLS Model Number A00-1025 | Sls Biophile, Ltd. | 2000 | — |
| −1 | K013461 | Nlite System,Model A00-1025 | Icn Photonics, Ltd. | 2002 | — |
| 0 (this device) | K024189 | Nlite System, Model#: A00-1025/A00-1033 | Icn Photonics, Ltd. | 2003 | — |
| +1 | K033461 | Candela Vbeam Pulse Dye Laser System | Candela Corp. | 2004 | — |
| +1 | K033331 | Candela Cbeam Pulse Dye Laser System | Candela Corp. | 2004 | — |
| +2 | K053047 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2006 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K063038 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 12 | 0 |
| 2009 | 8 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 15 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 22 | 0 |
| 2019 | 12 | 0 |
| 2020 | 20 | 0 |
| 2021 | 17 | 0 |
| 2022 | 30 | 0 |
| 2023 | 19 | 0 |
| 2024 | 34 | 0 |
| 2025 | 35 | 0 |
| 2026 | 20 | 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? (2)
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 |
|---|---|---|---|
| * | K000811 | Nlite System, SLS Model Number A00-1025 | 2000 |
| * | K013461 | Nlite System,Model A00-1025Summary page 1…ICN Photonics Ltd m i t e System, cleared August 2000,5 10(k) approval number KO0081 1, expanded Indications for Use 5 10(k) approval number K013461, January 2002. 4. Product Description The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:… | 2002 |
What descends from it? (328)
See all 3283 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 3 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033461 (Candela Corp., 2004) has gone furthest, with 316 descendants of its own.
- 6 other devices also cite its predicate K000811.
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 NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Inflammatory Acne Vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024189 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024189: Nlite System, Model#: A00-1025/A00-1033.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024189
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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