510(k) · Cleared

Cleared

Elite MPX Laser System with XPL Handpiece

K090235510(k) TraditionalCleared Mar 17, 200943-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 Mar 17, 2009 as substantially equivalent to K034030 (Cynosure, Inc., 2004) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 2004. 38 later devices descend from it.

Decided: Mar 17, 2009
Review: 43 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K034030 (2004). 2 ancestors in all. 38 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK034030 Apogee EliteCynosure, Inc. · 2004
This deviceK090235 Elite MPX Laser System with XPL HandpieceCynosure, Inc. · 2009
Descendant · cites it directly · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
Descendant · 2 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016
Descendant · 3 generations on · 30 of its ownK163222 Discovery Pico FamilyQuanta System Spa · 2016
Descendant · 4 generations on · 21 of its ownK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
Descendant · 5 generations on · 20 of its ownK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2015high 11 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 38 · See all

K152012EVO platformQuanta System Spa · 2015 · cites it directly37descendants
K160368EVO platformQuanta System Spa · 2016 · 2 generations on36descendants
K163222Discovery Pico FamilyQuanta System Spa · 2016 · 3 generations on30descendants
K171945Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 4 generations on21descendants
K172376Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017 · 5 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K034030	Apogee Elite	Cynosure, Inc.	2004	—
0 (this device)	K090235	Elite MPX Laser System with XPL Handpiece	Cynosure, Inc.	2009	—
+1	K152012	EVO platform	Quanta System Spa	2015	—
+2	K160368	EVO platform	Quanta System Spa	2016	—
+3	K163222	Discovery Pico Family	Quanta System Spa	2016	—
+4	K171945	Discovery Pico, Discovery Pico Plus	Quanta System Spa	2017	—
+5	K172376	Discovery Pico, Discovery Pico Plus	Quanta System Spa	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	2	0
2017	3	0
2018	2	0
2019	1	0
2020	2	0
2022	6	0
2023	1	0
2024	4	0
2025	11	0
2026	5	0

FIG. 1 — Lineage of K090235, 2004–2026Source: 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? (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	Applicant	Decided	Recalls
*	K034030	Apogee Elite Summary page 1 …ification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 Equivalent Device: Cynosure Apogee Elite (K034030) and Cynosure PhotoSilk Plus Pulsed Light System (KO51442) Device Description: The Cynosure Elite MPX L…	Cynosure, Inc.	2004	—
*	K051442	Photosilk Plus Pulsed Light System and Laser Attachment	Cynosure, Inc.	2006	—

Also cleared against K034030: 13 other devices →

What descends from it? (38)

See all 38

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152012	EVO platform	Quanta System Spa	2015	37

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?

None of the 2 ancestors has a recall.
Of its descendants, K152012 (Quanta System Spa, 2015) has gone furthest, with 37 descendants of its own.
13 other devices also cite its predicate K034030.

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. 2009, this device’s year, is highlighted.

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?

Elite MPX 755 nm: The Elite MPX Laser system 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 - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. Elite MiPX 1064 nm: The Elite MPX laser system is…

Read the full statement (257 words)

Elite MPX 755 nm:

The Elite MPX Laser system 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 - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Elite MiPX 1064 nm:

The Elite MPX laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as , but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliclitis (PFB).

XPL Handpiece:

The XPL Pulsed Light handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090235: Elite MPX Laser System with XPL Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090235

Report an extraction error

Are you the manufacturer?

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