510(k) · Cleared

Cleared

Affinity QS Q-Switched ND:Yag Laser System

K050382510(k) TraditionalCleared Sep 14, 2005211-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

Cynosure, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 14, 2005 after a 211-day review. The FDA summary names its predicate without a number. 179 later devices descend from it.

Decided: Sep 14, 2005
Review: 211 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

179 later devices descend from it, 3 citing it directly.

This deviceK050382 Affinity QS Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2005
Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · cites it directly · 76 of its ownK073549 Q-Plus TQuanta System Spa · 2008 · Recalled
Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014

Showing 5 of 179 descendants. See all descendants

Descendants cleared per year

2008high 25 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 179 · See all

K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
K073549Q-Plus TQuanta System Spa · 2008 · cites it directly76descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050382	Affinity QS Q-Switched ND:Yag Laser System	Cynosure, Inc.	2005	—
+1	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+1	K073549	Q-Plus T	Quanta System Spa	2008	1
+2	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+3	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers, Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	2	0
2012	1	0
2013	2	0
2014	5	0
2015	6	0
2016	6	0
2017	12	0
2018	12	0
2019	9	0
2020	14	0
2021	11	0
2022	25	0
2023	12	0
2024	22	0
2025	22	0
2026	17	0

FIG. 1 — Lineage of K050382, 2005–2026Source: 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
*	—	Medlite C6 Q-Switched Nd:YAG Laser system Named without a submission number			—

What descends from it? (179)

See all 179

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

Number	Device	Applicant	Decided	Descendants
K101916	Joule Multi-Platform System	Sciton, Inc	2011	111
K073549	Q-Plus T	Quanta System Spa	2008	76
K103539	Quanta System Duolite	Quanta System Spa	2011	0

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, K101916 (Sciton, Inc, 2011) has gone furthest, with 111 descendants of its own.

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 Affinity QS Laser is intended for the treatment of vascular lesions, pigmented lesions, and for hair removal, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050382 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050382: Affinity QS Q-Switched ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050382

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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