510(k) · Cleared

Cleared

Twilite, Twilite White

K003385510(k) TraditionalCleared Jan 25, 200186-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

Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 25, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided: Jan 25, 2001
Review: 86 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

68 later devices descend from it, 3 citing it directly.

This deviceK003385 Twilite, Twilite WhiteBiolase Technology, Inc. · 2001
Descendant · cites it directly · 56 of its ownK021227 Softlase G2-Surgical Diode Laser SystemZap Lasers, LLC · 2002
Descendant · cites it directly · 50 of its ownK082938 EzlaseBiolase Technology, Inc. · 2008
Descendant · 2 generations on · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
Descendant · 3 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
Descendant · 2 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2002high 9 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 68 · See all

K021227Softlase G2-Surgical Diode Laser SystemZap Lasers, LLC · 2002 · cites it directly56descendants
K082938EzlaseBiolase Technology, Inc. · 2008 · cites it directly50descendants
K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · 2 generations on50descendants
K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 3 generations on35descendants
K121286EPIC 10Biolase Technology, Inc. · 2012 · 2 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003385	Twilite, Twilite White	Biolase Technology, Inc.	2001	—
+1	K021227	Softlase G2-Surgical Diode Laser System	Zap Lasers, LLC	2002	—
+1	K082938	Ezlase	Biolase Technology, Inc.	2008	—
+2	K081214	Styla Microlaser and Stylaortho	Zap Lasers, LLC	2008	—
+3	K093852	Ezlase 3 Laser System	Biolase Technology, Inc.	2010	—
+2	K121286	EPIC 10	Biolase Technology, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0
2008	2	0
2009	3	0
2010	5	0
2011	2	0
2012	1	0
2013	5	0
2014	3	0
2015	2	0
2016	3	0
2017	2	0
2018	3	0
2019	5	0
2020	3	0
2021	2	0
2022	4	0
2023	2	0
2024	4	0
2025	9	0
2026	6	0

FIG. 1 — Lineage of K003385, 2001–2026Source: 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K021227	Softlase G2-Surgical Diode Laser System	Zap Lasers, LLC	2002	56
K082938	Ezlase	Biolase Technology, Inc.	2008	50
K083142	Picasso Laser System	Amd Lasers, LLC	2009	16

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, K021227 (Zap Lasers, LLC, 2002) has gone furthest, with 56 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/K003385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003385: Twilite, Twilite White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003385

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Record history

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