510(k) · Cleared

Cleared

Lasersmile

K030539510(k) TraditionalCleared Oct 10, 2003232-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 Oct 10, 2003 as substantially equivalent to K011041 (Biolase Technology, Inc., 2001) after a 232-day review. Its family tree reaches back 1 generation to 2001. 327 later devices descend from it.

Decided: Oct 10, 2003
Review: 232 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K011041 (2001). 327 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
This deviceK030539 LasersmileBiolase Technology, Inc. · 2003
Descendant · cites it directly · 289 of its ownK061898 EzlaseBiolase Technology, Inc. · 2007
Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · 4 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · cites it directly · 86 of its ownK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005

Showing 5 of 327 descendants. See all descendants

Descendants cleared per year

2005high 46 (2025) · low 1 (2005)2026

Most influential descendants

Showing 5 of 327 · See all

K061898EzlaseBiolase Technology, Inc. · 2007 · cites it directly289descendants
K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 4 generations on111descendants
K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005 · cites it directly86descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011041	Waterlase, Millennium	Biolase Technology, Inc.	2001	—
0 (this device)	K030539	Lasersmile	Biolase Technology, Inc.	2003	—
+1	K061898	Ezlase	Biolase Technology, Inc.	2007	—
+2	K072034	Diode Medical Laser Family, Models 4, 6, 30	Quanta System Spa	2007	—
+3	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+4	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+1	K050453	Odyssey 2.4G, Denlaser Elite, Model 002-00050	Ivoclar Vivadent, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	5	0
2008	9	0
2009	8	0
2010	14	0
2011	8	0
2012	9	0
2013	13	0
2014	13	0
2015	15	0
2016	12	0
2017	12	0
2018	15	0
2019	13	0
2020	21	0
2021	12	0
2022	27	0
2023	17	0
2024	30	0
2025	46	0
2026	24	0

FIG. 1 — Lineage of K030539, 2001–2026Source: 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; 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	K91994	Twilite Number could not be read Summary page 3 …materiaIs or specifications prescnted herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in IS91994 (TwiliteTM,original indications for use), and in KO1 1041 (Waferlase@, expanded indications for use). Conclusion: Lase…
*	K011041	Waterlase, Millennium	Biolase Technology, Inc.	2001	—

Also cleared against K011041: 3 other devices →

What descends from it? (327)

See all 327

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

Number	Device	Applicant	Decided	Descendants
K061898	Ezlase	Biolase Technology, Inc.	2007	289
K050453	Odyssey 2.4G, Denlaser Elite, Model 002-00050	Ivoclar Vivadent, Inc.	2005	86
K063152	Claros Dental Laser System	Elexxion AG	2007	53
K062071	Prometey, Model G1-03	Spectrum International	2006	17
K083142	Picasso Laser System	Amd Lasers, LLC	2009	16
K081652	Claros Nano Dental Laser System	Elexxion AG	2008	9
K100474	Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W	Quicklase Limited	2010	8

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?

Its one ancestor has no recall.
Of its descendants, K061898 (Biolase Technology, Inc., 2007) has gone furthest, with 289 descendants of its own.
3 other devices also cite its predicate K011041.

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?

Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies…

Read the full statement (168 words)

Dental Soft Tissue Indications for:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

Excisional and incisional biopsies

Exposure of unerupted teeth

Fibroma removal

Frenectomy

Frenotomy

Gingival troughing for crown impressions

Gingivectomy

Gingivoplasty

Gingival incision and excision

Hemostasis and coagulation

Implant recovery

Incision and drainage of abscess

Leukoplakia

Operculectomy

Oral papillectomies

Pulpotomy

Pulpotomy as an adjunct to root canal therapy

Reduction of gingival hypertrophy

Soft tissue crown lengthening

Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa

Vestibuloplasty

Laser Periodontal procedures, including:

Laser soft tissue curettage

Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket

Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Tooth whitening procedures, including:

Light activation for bleaching materials for teeth whitening

Laser-assisted whitening/bleaching of teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030539 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030539: Lasersmile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030539

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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