510(k) · Cleared

Cleared

Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength

K091537510(k) TraditionalCleared Sep 3, 2009100-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 3, 2009 after a 100-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.

Decided: Sep 3, 2009
Review: 100 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

40 later devices descend from it, 2 citing it directly.

This deviceK091537 Cynosure Smartlipo Multiwavelength Laser with 1440NM WavelengthCynosure, Inc. · 2009
Descendant · cites it directly · 39 of its ownK102541 Cynosure Cellulaze LaserCynosure, Inc. · 2012
Descendant · cites it directly · 25 of its ownK121127 Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM…Cynosure, Inc. · 2012
Descendant · 2 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
Descendant · 3 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
Descendant · 2 generations on · 12 of its ownK201801 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2012high 7 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 40 · See all

K102541Cynosure Cellulaze LaserCynosure, Inc. · 2012 · cites it directly39descendants
K121127Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersCynosure, Inc. · 2012 · cites it directly25descendants
K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 2 generations on23descendants
K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 3 generations on13descendants
K201801Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K091537	Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength	Cynosure, Inc.	2009	—
+1	K102541	Cynosure Cellulaze Laser	Cynosure, Inc.	2012	—
+1	K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers	Cynosure, Inc.	2012	—
+2	K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers…	Med-Fibers, Inc.	2013	—
+3	K170366	Laser Peripherals, LLC Family of Bare Laser Fibers	Laser Peripherals, LLC	2017	—
+2	K201801	Rapid Acoustic Pulse Device	Soliton, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2013	2	0
2014	1	0
2015	2	0
2016	3	0
2017	2	0
2020	1	0
2021	4	0
2022	4	0
2023	5	0
2024	6	0
2025	7	0
2026	1	0

FIG. 1 — Lineage of K091537, 2009–2026Source: 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 Smartlipo Multiwavelength Laser Named without a submission number			—

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K102541	Cynosure Cellulaze Laser	Cynosure, Inc.	2012	39
K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers	Cynosure, Inc.	2012	25

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, K102541 (Cynosure, Inc., 2012) has gone furthest, with 39 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. 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?

The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091537 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091537: Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091537

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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