510(k) · Cleared

Cleared

Cynosure Apogee-TKS Dermatological Laser

K992757510(k) TraditionalCleared Jun 29, 2000318-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 29, 2000 after a 318-day review. The FDA summary names its predicate without a number. 340 later devices descend from it.

Decided: Jun 29, 2000
Review: 318 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

340 later devices descend from it, 8 citing it directly.

This deviceK992757 Cynosure Apogee-TKS Dermatological LaserCynosure, Inc. · 2000
Descendant · cites it directly · 174 of its ownK020849 Apex 800 Laser System, Model Apex 800Iridex Corp · 2002
Descendant · 2 generations on · 173 of its ownK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
Descendant · 2 generations on · 172 of its ownK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
Descendant · 3 generations on · 171 of its ownK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
Descendant · 2 generations on · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008

Showing 5 of 340 descendants. See all descendants

Descendants cleared per year

2002high 47 (2022) · low 1 (2006)2026

Most influential descendants

Showing 5 of 340 · See all

K020849Apex 800 Laser System, Model Apex 800Iridex Corp · 2002 · cites it directly174descendants
K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003 · 2 generations on173descendants
K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005 · 2 generations on172descendants
K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006 · 3 generations on171descendants
K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · 2 generations on169descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992757	Cynosure Apogee-TKS Dermatological Laser	Cynosure, Inc.	2000	—
+1	K020849	Apex 800 Laser System, Model Apex 800	Iridex Corp	2002	—
+2	K032846	Spectra Pulsed Diode Laser, Model DR-1	Spectragenics, Inc.	2003	—
+2	K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	2005	—
+3	K060839	Abc Hair Removal System	Palomar Medical Technologies, Inc.	2006	—
+2	K053527	Spectra Hair Removal Laser	Spectragenics, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2008	6	0
2009	3	0
2010	1	0
2011	2	0
2012	6	0
2013	7	0
2014	11	0
2015	10	0
2016	6	0
2017	12	0
2018	20	0
2019	13	0
2020	15	0
2021	23	0
2022	47	0
2023	40	0
2024	39	0
2025	40	0
2026	27	0

FIG. 1 — Lineage of K992757, 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
*	—	Cynosure Apogee Laser Named without a submission number			—

What descends from it? (340)

See all 340

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

Number	Device	Applicant	Decided	Descendants
K020849	Apex 800 Laser System, Model Apex 800	Iridex Corp	2002	174
K042474	ARION	Wavelight Laser Technologie AG	2004	114
K020412	Depilase Twin Lase Laser System	Depilase Group, Ltd.	2002	106
K032218	Adept 1064/532/755 Laser	Adept Medical Concepts	2003	104
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
K032221	Adept 1064/755 Laser	Adept Medical Concepts	2003	0
K030508	Depilase Trio Lase Laser System	Depilase Group, Ltd.	2003	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, K020849 (Iridex Corp, 2002) has gone furthest, with 174 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 laser is indicated for vascular lesion removal

and stable, long-term, or permanent hair reduction.

Permanent hair reduction is defined as long-term, stable reduction in the

number of hairs re-growing after a treatment regime. The number of hairs

re-growing must be stable over a time greater than the duration of the

complete growth cycle of hair follicles, which varies from 4-12 months

according to body location. Permanent hair reduction does not necessarily

imply the elimination of all hairs in the treated area.

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/K992757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992757: Cynosure Apogee-TKS 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/K992757

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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