510(k) · Cleared

Cleared

Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers

K121127510(k) SpecialCleared May 13, 201230-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 May 13, 2012 as substantially equivalent to K091537 (Cynosure, Inc., 2009) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1994. 25 later devices descend from it.

Decided: May 13, 2012
Review: 30 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K941909 (1994). 8 ancestors in all. 25 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK941909 Mega Beam Lateral FireHogan & Hartson · 1994
1 generation backK112987 Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011
This deviceK121127 Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM…Cynosure, Inc. · 2012
Descendant · cites it directly · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
Descendant · 2 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
Descendant · 3 generations on · 5 of its ownK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
Descendant · 2 generations on · 5 of its ownK140470 Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire…Oberon GmbH Fiber Technologies · 2014
Descendant · cites it directly · 5 of its ownK131473 (Quanta System) Surgical Laser FibersQuanta System Spa · 2013 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2013high 5 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 25 · See all

K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · cites it directly23descendants
K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 2 generations on13descendants
K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 3 generations on5descendants
K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies · 2014 · 2 generations on5descendants
K131473(Quanta System) Surgical Laser FibersQuanta System Spa · 2013 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941909	Mega Beam Lateral Fire	Hogan & Hartson	1994	—
−1	K112987	Twister Side Fire Optical Fiber Delivery System	Biolitec Medical Devices, Inc.	2011	—
0 (this device)	K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers	Cynosure, Inc.	2012	—
+1	K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers…	Med-Fibers, Inc.	2013	—
+2	K170366	Laser Peripherals, LLC Family of Bare Laser Fibers	Laser Peripherals, LLC	2017	—
+3	K220189	LISA Laser Surgical Fibers	Omni-Guide Holdings, Inc.	2022	—
+2	K140470	Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial…	Oberon GmbH Fiber Technologies	2014	—
+1	K131473	(Quanta System) Surgical Laser Fibers	Quanta System Spa	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	3	0
2006	1	0
2009	1	0
2012	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K121127, 1994–2026Source: 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? (3)

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
*	K091537	Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength Summary page 2 …rgery and in Dermatology) Classification: Class 11 Predicate Devices (Claiming Substantial BEquivalence): Cynosure Multiwavelength Laser with 1440nm Wavelength K09 1537 Cynosure Cellulaze Laser and Cellulaze Delivery Kit K102541 TwisterTM Side-Fifing Optic Delivery System K112987 Summary Descri…	Cynosure, Inc.	2009	—
*	K102541	Cynosure Cellulaze Laser Summary page 2 …edicate Devices (Claiming Substantial BEquivalence): Cynosure Multiwavelength Laser with 1440nm Wavelength K09 1537 Cynosure Cellulaze Laser and Cellulaze Delivery Kit K102541 TwisterTM Side-Fifing Optic Delivery System K112987 Summary Description of the Device: SideLaze800TM is an optional side-firin…	Cynosure, Inc.	2012	—
*	K112987	Twister Side Fire Optical Fiber Delivery System Summary page 2 …Cynosure Multiwavelength Laser with 1440nm Wavelength K09 1537 Cynosure Cellulaze Laser and Cellulaze Delivery Kit K102541 TwisterTM Side-Fifing Optic Delivery System K112987 Summary Description of the Device: SideLaze800TM is an optional side-firing fiber optic accessory to the currently cleared Cyno…	Biolitec Medical Devices, Inc.	2011	—

Also cleared against K091537: 1 other device →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…	Med-Fibers, Inc.	2013	23
K131473	(Quanta System) Surgical Laser Fibers	Quanta System Spa	2013	5
K141511	SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers	Cynosure, Inc.	2015	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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K124003 (Med-Fibers, Inc., 2013) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K091537.

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. 2012, 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?

SideLaze800 is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800 may be used in combination with a Cynosure SMA-compatible laser system for the same indications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121127 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121127

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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