510(k) · Cleared

Cleared

Starlite 2006

K052604510(k) TraditionalCleared Dec 16, 200586-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

Laser Dental Innovations · GEX Powered Laser Surgical Instrument

Cleared on Dec 16, 2005 after an 86-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.

Decided: Dec 16, 2005
Review: 86 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

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

This deviceK052604 Starlite 2006Laser Dental Innovations · 2005
Descendant · cites it directly · 0 of its ownK082445 CURATIVE980 Diode LaserOroscience, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K082445CURATIVE980 Diode LaserOroscience, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052604	Starlite 2006	Laser Dental Innovations	2005	—
+1	K082445	CURATIVE980 Diode Laser	Oroscience, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K052604, 2005–2008Source: 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; 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	K091994	FDA’s K091994 is Mountaineer Laminoplasty System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Depuy Spine, Inc.	2010	—

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
K082445	CURATIVE980 Diode Laser	Oroscience, Inc.	2008	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, K082445 (Oroscience, Inc., 2008) 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 Starlite 2006 will be used with the following lasers for the excision, ablation., vaporization and hemostasis of soft tissue. Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating…

Read the full statement (130 words)

The Starlite 2006 will be used with the following lasers for the excision, ablation., vaporization and hemostasis of soft tissue.

Diolase ST produced by American Dental Technologies (810 Nm operating wavelength)

Twilight produced by Biolase (810 Nm operating wavelength)

Diodent produced by Hoya Con Bio (810 Nm operating wavelength)

Softlase produced by Zap Lasers (810 Nm operating wavelength)

Aurora produced by Premier Lasers (810 Nm operating wavelength)

indications of use summary statement:

The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths.

The StarLite will become an integral part of the laser system and by default be cleared for the same indications and procedures as the laser it is deployed on

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052604 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052604: Starlite 2006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052604

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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