510(k) · Cleared

Cleared

Megabeam Sidefiber Fiber Optic Delivery System

K060050510(k) TraditionalCleared Jan 23, 200617-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

Biolitec, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 23, 2006 after a 17-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.

Decided: Jan 23, 2006
Review: 17 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

28 later devices descend from it, 1 citing it directly.

This deviceK060050 Megabeam Sidefiber Fiber Optic Delivery SystemBiolitec, Inc. · 2006
Descendant · cites it directly · 27 of its ownK112987 Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011
Descendant · 2 generations on · 25 of its ownK121127 Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM…Cynosure, Inc. · 2012
Descendant · 3 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
Descendant · 4 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
Descendant · 5 generations on · 5 of its ownK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2011high 5 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 28 · See all

K112987Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011 · cites it directly27descendants
K121127Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersCynosure, Inc. · 2012 · 2 generations on25descendants
K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 3 generations on23descendants
K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 4 generations on13descendants
K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 5 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K060050	Megabeam Sidefiber Fiber Optic Delivery System	Biolitec, Inc.	2006	—
+1	K112987	Twister Side Fire Optical Fiber Delivery System	Biolitec Medical Devices, Inc.	2011	—
+2	K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers	Cynosure, Inc.	2012	—
+3	K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers…	Med-Fibers, Inc.	2013	—
+4	K170366	Laser Peripherals, LLC Family of Bare Laser Fibers	Laser Peripherals, LLC	2017	—
+5	K220189	LISA Laser Surgical Fibers	Omni-Guide Holdings, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	2	0
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 K060050, 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

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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	Recalls
*	—	Biolitec Inc MegaBeam Lateral Fire Fiber Optic Delivery System Named without a submission number	—
*	—	Lumenis DuoTome Side Firing Fiber Named without a submission number	—
*	—	Trimedyne VAPORMAX side firing fiber Named without a submission number	—

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K112987	Twister Side Fire Optical Fiber Delivery System	Biolitec Medical Devices, Inc.	2011	27

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, K112987 (Biolitec Medical Devices, Inc., 2011) has gone furthest, with 27 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 Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060050 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060050: Megabeam Sidefiber Fiber Optic Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060050

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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