510(k) · Cleared

Cleared

Cynosure Apogee-TKS II Dermatological Laser

K031488510(k) TraditionalCleared Jun 4, 200323-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 Jun 4, 2003 after a 23-day review. The FDA summary names its predicate without a number. 142 later devices descend from it.

Decided: Jun 4, 2003
Review: 23 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

142 later devices descend from it, 4 citing it directly.

This deviceK031488 Cynosure Apogee-TKS II Dermatological LaserCynosure, Inc. · 2003
Descendant · cites it directly · 136 of its ownK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
Descendant · 2 generations on · 133 of its ownK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Descendant · cites it directly · 114 of its ownK042474 ARIONWavelight Laser Technologie AG · 2004
Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008

Showing 5 of 142 descendants. See all descendants

Descendants cleared per year

2004high 18 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 142 · See all

K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp. · 2005 · cites it directly136descendants
K050673Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · 2 generations on133descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
K042474ARIONWavelight Laser Technologie AG · 2004 · cites it directly114descendants
K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031488	Cynosure Apogee-TKS II Dermatological Laser	Cynosure, Inc.	2003	—
+1	K043251	Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B	Candela Corp.	2005	—
+2	K050673	Candela Family of Pulse Dye Laser Systems	Candela Corp.	2005	2
+2	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—
+1	K042474	ARION	Wavelight Laser Technologie AG	2004	—
+2	K081352	Profile Multi-Platform System	Sciton, Inc	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	3	0
2006	1	0
2007	1	0
2008	6	0
2009	4	0
2010	3	0
2011	1	0
2012	1	0
2014	3	0
2015	6	0
2016	1	0
2017	4	0
2018	10	0
2019	8	0
2020	11	0
2021	9	0
2022	18	0
2023	10	0
2024	14	0
2025	15	0
2026	11	0

FIG. 1 — Lineage of K031488, 2003–2026Source: 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

Get a 510(k) Report

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
*	—	Cynosure Apogee-TKS Named without a submission number			—

What descends from it? (142)

See all 142

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

Number	Device	Applicant	Decided	Descendants
K043251	Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B	Candela Corp.	2005	136
K042474	ARION	Wavelight Laser Technologie AG	2004	114
K032991	Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX	Light Age, Inc.	2004	61
K090571	Alma Lasers ALEX755 Module	Alma Lasers, Ltd.	2009	58

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, K043251 (Candela Corp., 2005) has gone furthest, with 136 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 Cynosure Apogee-TKS I1 Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin.

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031488: Cynosure Apogee-TKS II Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031488

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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