510(k) · Cleared

Cleared

Megabeam Endo-Ent Probe

K113858510(k) TraditionalCleared Jan 24, 201225-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 Medical Devices, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 24, 2012 as substantially equivalent to K952772 (Ceram Optec, Inc., 1995) after a 25-day review. Its family tree reaches back 1 generation to 1995. 24 later devices descend from it.

Decided: Jan 24, 2012
Review: 25 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952772 (1995). 24 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK952772 Megabeam Endo-Ent ProbeCeram Optec, Inc. · 1995
This deviceK113858 Megabeam Endo-Ent ProbeBiolitec Medical Devices, 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 24 descendants. See all descendants

Descendants cleared per year

2013high 5 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 24 · 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
−1	K952772	Megabeam Endo-Ent Probe	Ceram Optec, Inc.	1995	—
0 (this device)	K113858	Megabeam Endo-Ent Probe	Biolitec Medical Devices, 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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	1	0
2015	1	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 K113858, 1995–2026Source: 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
*	K952772	Megabeam Endo-Ent Probe Summary page 1 …tec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Classification Name Surgical laser accessory Predicate Devices MegaBeam Endo-ENT Probe, (K952772). Intended Use/Indication for Use The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic p…	Ceram Optec, Inc.	1995	—

Also cleared against K952772: 1 other device →

What descends from it? (24)

See all 24

2 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

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, K124003 (Med-Fibers, Inc., 2013) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K952772.

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?

The MegaBeam Endo-ENT Probe is intended as an aid for otologic procedures, for use in incision, excision, coagulation and. vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113858: Megabeam Endo-Ent Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113858

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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