510(k) · Cleared

Cleared

Nlite System,Model A00-1025

K013461510(k) TraditionalCleared Jan 17, 200291-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Icn Photonics, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Jan 17, 2002 as substantially equivalent to K000811 (Sls Biophile, Ltd., 2000) after a 91-day review. Its family tree reaches back 1 generation to 2000. 711 later devices descend from it.

Decided: Jan 17, 2002
Review: 91 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000811 (2000). 711 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
This deviceK013461 Nlite System,Model A00-1025Icn Photonics, Ltd. · 2002
Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · cites it directly · 328 of its ownK024189 Nlite System, Model#: A00-1025/A00-1033Icn Photonics, Ltd. · 2003
Descendant · cites it directly · 318 of its ownK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002

Showing 5 of 711 descendants. See all descendants

Descendants cleared per year

2002high 82 (2025) · low 3 (2002)2026

Most influential descendants

Showing 5 of 711 · See all

K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 2 generations on519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants
K024189Nlite System, Model#: A00-1025/A00-1033Icn Photonics, Ltd. · 2003 · cites it directly328descendants
K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002 · cites it directly318descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—
0 (this device)	K013461	Nlite System,Model A00-1025	Icn Photonics, Ltd.	2002	—
+1	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+2	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+3	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+1	K024189	Nlite System, Model#: A00-1025/A00-1033	Icn Photonics, Ltd.	2003	—
+1	K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	6	0
2004	8	0
2005	7	0
2006	7	0
2007	12	0
2008	25	0
2009	14	0
2010	19	0
2011	25	0
2012	20	0
2013	24	0
2014	29	0
2015	27	0
2016	37	0
2017	31	0
2018	33	0
2019	21	0
2020	41	0
2021	31	0
2022	52	0
2023	41	0
2024	70	0
2025	82	0
2026	46	0

FIG. 1 — Lineage of K013461, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K000811	Nlite System, SLS Model Number A00-1025 Summary page 1 …stem Primary Classification Name: Laser Powered Surgical Instrument 3. Predicate Devices e ICN Photonics Ltd NLite System, cleared August 2000, 510(k) approval number K000811. 4. Product Description The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following: e Main laser con…	Sls Biophile, Ltd.	2000	—

Also cleared against K000811: 6 other devices →

What descends from it? (711)

See all 711

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…	Altus Medical, Inc.	2002	665
K024189	Nlite System, Model#: A00-1025/A00-1033	Icn Photonics, Ltd.	2003	328
K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	318
K020958	Candela Cbeam Pulsed Dye Laser System	Candela Corp.	2002	231
K032397	Dual Yellow Laser, Model Dual Yellow D10B	Norseld Pty., Ltd.	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?

Its one ancestor has no recall.
Of its descendants, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
6 other devices also cite its predicate K000811.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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 wrinkles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013461: Nlite System,Model A00-1025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013461

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026