510(k) · Cleared
ClearedNlite System,Model A00-1051
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 4, 2002 as substantially equivalent to K013043 (Candela Corp., 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 4, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000811 (2000). 4 ancestors in all, the oldest K921842 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
- 1 generation backK013043 Candela Clearbeam Pulsed Dye LaserCandela Corp. · 2001
- This deviceK020729 Nlite System,Model A00-1051Icn Photonics, Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK032397 Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK132976 AdvatxAdvalight Aps · 2014
- Descendant · 3 generations on · 0 of its ownK250189 AdvaTxAdvalight Aps · 2025
Most influential descendants
Showing 3 of 3 · See allView 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 | K013043 | Candela Clearbeam Pulsed Dye Laser | Candela Corp. | 2001 | — |
| 0 (this device) | K020729 | Nlite System,Model A00-1051 | Icn Photonics, Ltd. | 2002 | — |
| +1 | K032397 | Dual Yellow Laser, Model Dual Yellow D10B | Norseld Pty., Ltd. | 2004 | — |
| +2 | K132976 | Advatx | Advalight Aps | 2014 | — |
| +3 | K250189 | AdvaTx | Advalight Aps | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 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? (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 |
|---|---|---|---|
| * | K013043 | Candela Clearbeam Pulsed Dye Laser | 2001 |
| * | K921842 | Cynosure Photgenica V Cutaneous Vas. Lesion LaserSummary page 1…Device Name : Mite System Primary Classification Name : Laser Powered Surgical Instrument. 3. Predicate Devices : KO13043 - Candela Clearbeam Pulse Dye Laser System K921842 - Cynosure. Photogenica V Pulsed Dye Laser. 4. Product Description The NLite System is a ffashIamp pumped, pulsed dye laser co… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032397 | Dual Yellow Laser, Model Dual Yellow D10B | 2004 | 2 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K032397 (Norseld Pty., Ltd., 2004) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K013043.
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 laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as :Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020729: Nlite System,Model A00-1051.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020729
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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