510(k) · Cleared

Cleared

Maxiflex Fiber Optic Energy Delivery System

K013300510(k) TraditionalCleared Apr 16, 2002195-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

Technology Delivery Systems, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 16, 2002 after a 195-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided: Apr 16, 2002
Review: 195 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK013300 Maxiflex Fiber Optic Energy Delivery SystemTechnology Delivery Systems, Inc. · 2002
Descendant · cites it directly · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013300	Maxiflex Fiber Optic Energy Delivery System	Technology Delivery Systems, Inc.	2002	—
+1	K090281	Accutech Family of Powerflex Laser Delivery Devices	Accutech Medical Technologies, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K013300, 2002–2009Source: 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? (2)

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
*	—	StrateFire Named without a submission number			—
*	—	InnovaQuartz SE Named without a submission number			—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K090281	Accutech Family of Powerflex Laser Delivery Devices	Accutech Medical Technologies, Inc.	2009	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?

Of its descendants, K090281 (Accutech Medical Technologies, Inc., 2009) has gone furthest, with 0 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 MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver laser energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system. The device is suitable…

Read the full statement (98 words)

The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver laser energy

to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and

cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising,

excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted

above using a contact fiber optic based laser system.

The device is suitable for use for all applications for which the laser output unit is cleared,

including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy,

gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology,

urology, ophthalmology and pulmonary surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013300 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013300: Maxiflex Fiber Optic Energy 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/K013300

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026