510(k) · Cleared

Cleared

ELIPO

K073715510(k) TraditionalCleared Apr 23, 2008114-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

Syneron Medical, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Apr 23, 2008 as substantially equivalent to K062321 (Cynosure, Inc., 2006) after a 114-day review. Its family tree reaches back 1 generation to 2006. 81 later devices descend from it.

Decided: Apr 23, 2008
Review: 114 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K062321 (2006). 81 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK062321 Smartlipo ND:Yag LaserCynosure, Inc. · 2006
This deviceK073715 ELIPOSyneron Medical, Ltd. · 2008
Descendant · cites it directly · 80 of its ownK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
Descendant · 2 generations on · 78 of its ownK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 33 of its ownK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2009high 11 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 81 · See all

K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D. · 2009 · cites it directly80descendants
K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D. · 2011 · 2 generations on78descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC · 2012 · 2 generations on33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K062321	Smartlipo ND:Yag Laser	Cynosure, Inc.	2006	—
0 (this device)	K073715	ELIPO	Syneron Medical, Ltd.	2008	—
+1	K090126	Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP…	Fotona D.D.	2009	—
+2	K101306	SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…	Fotona D.D.	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+2	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K120235	Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers…	Aerolase Medical Lasers, LLC	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2012	2	0
2014	2	0
2015	3	0
2016	3	0
2017	4	0
2018	4	0
2019	3	0
2020	5	0
2021	5	0
2022	11	0
2023	7	0
2024	10	0
2025	11	0
2026	9	0

FIG. 1 — Lineage of K073715, 2006–2026Source: 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
*	K062321	Smartlipo ND:Yag Laser Summary page 1 …ite (eLipo) device that is substantially equivalent to the following cleared device: Cynosure SmartLipo Laser (Cynosure Inc., K06232 1). Device Description: The LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd:YAG laser system. It is…	Cynosure, Inc.	2006	—

Also cleared against K062321: 7 other devices →

What descends from it? (81)

See all 81

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

Number	Device	Applicant	Decided	Descendants
K090126	Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…	Fotona D.D.	2009	80

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?

Its one ancestor has no recall.
Of its descendants, K090126 (Fotona D.D., 2009) has gone furthest, with 80 descendants of its own.
7 other devices also cite its predicate K062321.

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. 2008, 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 LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073715 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073715: ELIPO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073715

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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