510(k) · Cleared

Cleared

Twister Side Fire Optical Fiber Delivery System

K112987510(k) TraditionalCleared Dec 16, 201171-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 Dec 16, 2011 as substantially equivalent to K941909 (Hogan & Hartson, 1994) and 4 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1994. 27 later devices descend from it.

Decided: Dec 16, 2011
Review: 71 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K941909 (1994). 5 ancestors in all. 27 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK941909 Mega Beam Lateral FireHogan & Hartson · 1994
This deviceK112987 Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011
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 · 4 generations on · 5 of its ownK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
Descendant · 3 generations on · 5 of its ownK140470 Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire…Oberon GmbH Fiber Technologies · 2014

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2012high 5 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 27 · See all

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
K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 4 generations on5descendants
K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies · 2014 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941909	Mega Beam Lateral Fire	Hogan & Hartson	1994	—
0 (this device)	K112987	Twister Side Fire Optical Fiber Delivery System	Biolitec Medical Devices, Inc.	2011	—
+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	—
+4	K220189	LISA Laser Surgical Fibers	Omni-Guide Holdings, Inc.	2022	—
+3	K140470	Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial…	Oberon GmbH Fiber Technologies	2014	—

Other ancestors by year cleared

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

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	1	0
2022	2	0
2023	2	0
2024	3	0
2025	5	0
2026	1	0

FIG. 1 — Lineage of K112987, 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

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What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K940008	FDA’s K940008 is Glycated Protein Calibrators Our reading of the summary gave K940008, FDA’s number for Glycated Protein Calibrators (Primus Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Megabeam® Lateral Side Fire Fiber Optic Delivery System”. Kept off the family tree. Summary page 1 …Road East Longmeadow, Massachusetts 01028 Classification Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery…	Primus Corp.	1994	—
*	K941909	Mega Beam Lateral Fire Summary page 1 …Longmeadow, Massachusetts 01028 Classification Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery System is…	Hogan & Hartson	1994	—
*	K943444	Megabeam Lateral Fire Summary page 1 …ow, Massachusetts 01028 Classification Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery System is a delive…	Ceram Optec, Inc.	1994	—
*	K943526	Megabeam Lateral Fire Fiber Optic Delivery System Summary page 1 …usetts 01028 Classification Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery System is a delivery accesso…	Ceram Optec, Inc.	1994	—
*	K943527	Megabeam Lateral Fire Summary page 1 …28 Classification Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery System is a delivery accessory used to…	Ceram Optec, Inc.	1994	—
*	K060050	Megabeam Sidefiber Fiber Optic Delivery System Summary page 1 …ation Name Surgical laser & accessories Predicate Devices Megabeam® Lateral] Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K(943526, K(943527 and K(060050) Intended Use/Indication for Use The TwisterM Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver opti…	Biolitec, Inc.	2006	—

Also cleared against K941909: 2 other devices →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers	Cynosure, Inc.	2012	25
K120437	Twister Side-Fire Fiber Optic Delivery System	Biolitec Sia (Latvia)	2012	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?

None of the 5 ancestors has a recall.
Of its descendants, K121127 (Cynosure, Inc., 2012) has gone furthest, with 25 descendants of its own.
2 other devices also cite its predicate K941909.

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. 2011, 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 TwisterTM Side-Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The TwiSterTM1 Side-Firing Fiber Optic Delivery System is indicated for hernostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can Ibe 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/K112987 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112987: Twister Side Fire Optical Fiber Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112987

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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