510(k) · Cleared

Cleared

Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn and Accessories

K944704510(k) TraditionalCleared Jan 6, 1995105-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

Xintec Corporation · GEX Powered Laser Surgical Instrument

Cleared on Jan 6, 1995 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 113 later devices descend from it.

Decided: Jan 6, 1995
Review: 105 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK944704 Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle…Xintec Corporation · 1995
Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014

Showing 5 of 113 descendants. See all descendants

Descendants cleared per year

2010high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 113 · See all

K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 3 generations on57descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944704	Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn…	Xintec Corporation	1995	—
+1	K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	—
+2	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+4	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+3	K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers, Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2014	3	0
2015	5	0
2016	1	0
2017	4	0
2018	8	0
2019	6	0
2020	11	0
2021	8	0
2022	18	0
2023	9	0
2024	13	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K944704, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (113)

See all 113

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

Number	Device	Applicant	Decided	Descendants
K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	112

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, K082230 (Xintec Corporation, 2010) has gone furthest, with 112 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	—

https://510kreport.com/device/K944704 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944704: Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944704

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026