510(k) · Cleared

Cleared

Innovaquartz General Shape Laser Fiber

K994010510(k) TraditionalCleared Dec 17, 199921-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

Innovaquartz · GEX Powered Laser Surgical Instrument

Cleared on Dec 17, 1999 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 233 later devices descend from it.

Decided: Dec 17, 1999
Review: 21 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

233 later devices descend from it, 5 citing it directly.

This deviceK994010 Innovaquartz General Shape Laser FiberInnovaquartz · 1999
Descendant · cites it directly · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · 4 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009

Showing 5 of 233 descendants. See all descendants

Descendants cleared per year

2002high 28 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 233 · See all

K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · cites it directly225descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 4 generations on177descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K994010	Innovaquartz General Shape Laser Fiber	Innovaquartz	1999	—
+1	K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	5
+2	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+3	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—
+4	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+4	K090164	Ceralas Multiwavelength 980/1470NM Diode Laser	Biolitec, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2005	1	0
2006	1	0
2007	3	0
2008	10	0
2009	4	0
2010	9	0
2011	5	0
2012	4	0
2013	9	0
2014	10	0
2015	12	0
2016	11	0
2017	6	0
2018	11	0
2019	7	0
2020	14	0
2021	10	0
2022	23	0
2023	13	0
2024	24	0
2025	28	0
2026	15	0

FIG. 1 — Lineage of K994010, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (233)

See all 233

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

Number	Device	Applicant	Decided	Descendants
K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	225
K073496	Optilite Holmium Laser Fibers	Cook Urological, Inc.	2008	4
K020673	Wave Form Manufacturing Prolase General Shaped Fiber	Wave Form Mfg., Inc.	2002	2
K022338	Optical Integrity General Shaped Fiber	Optical Integrity, Inc.	2002	1
K021686	Laser Fiber GF500	W.O.M. World of Medicine AG	2002	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, K050738 (Fibertech GmbH, 2005) has gone furthest, with 225 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 InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, coagulation, hemostasis and incision of soft tissue. It is designed for use with ND:Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994010 · printed Nov 3, 2026

Cite this page

510(k) Report. “K994010: Innovaquartz General Shape Laser Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K994010

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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