510(k) · Cleared

Cleared

Gemini 810+980 Soft Tissue Laser

K192617510(k) TraditionalCleared Feb 20, 2020150-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

Azena Medical, LLC · GEX Powered Laser Surgical Instrument

Cleared on Feb 20, 2020 as substantially equivalent to K152032 (Azena Medical, LLC, 2015) after a 150-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.

Decided: Feb 20, 2020
Review: 150 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 8 generations to K922901 (1992). 26 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
7 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
6 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
5 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
4 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
3 generations backK063384 Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc. · 2007
2 generations backK100474 Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980…Quicklase Limited · 2010
1 generation backK152032 ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015
This deviceK192617 Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
Descendant · cites it directly · 1 of its ownK210350 Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
Descendant · 2 generations on · 0 of its ownK260765 Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC · 2026

Most influential descendants

Showing 2 of 2 · See all

K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021 · cites it directly1descendant
K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K922901	Incisor I Pulsed ND:Yag Laser System	Buckman Co., Inc.	1992	—
−7	K972325	Pulsemaster 1000 ST Dental Laser System	American Dental Technologies, Inc.	1997	—
−6	K983058	Ceralas D Laser System, Model # Ceralas D15	Ceram Optec, Inc.	1998	—
−5	K991891	Ceralas Diode Laser System, Model Ceralas D15	Ceram Optec, Inc.	1999	—
−4	K053161	Sirolaser	Sirona Dental Systems GmbH	2006	—
−3	K063384	Diodent Micro Dental Laser System, Models 810 and 980	Hoya Conbio, Inc.	2007	—
−2	K100474	Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model…	Quicklase Limited	2010	—
−1	K152032	ELUMI 810 + 980 Soft Tissue Laser	Azena Medical, LLC	2015	—
0 (this device)	K192617	Gemini 810+980 Soft Tissue Laser	Azena Medical, LLC	2020	—
+1	K210350	Gemini 2 810+980 Soft Tissue Laser	Azena Medical, LLC	2021	—
+2	K260765	Gemini NOVA 810+980 Soft Tissue Laser	Azena Medical, LLC	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1996	1	0
1997	2	0
1998	3	0
1999	2	0
2000	1	0
2001	2	0
2003	1	0
2005	2	0
2007	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2026	1	0

FIG. 1 — Lineage of K192617, 1992–2026Source: 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

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K152032	ELUMI 810 + 980 Soft Tissue Laser Summary page 6 …ary Predicate Device: Company: Azena Medical, LLC Device: Elumi 810+980 Soft Tissue Laser 510(k): K152032 Date Cleared: September 16, 2015 Reference Predicate Device: Company: Biolase T…	Azena Medical, LLC	2015	—
†	K121286	EPIC 10	Biolase Technology, Inc.	2012	—

Also cleared against K152032: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K210350	Gemini 2 810+980 Soft Tissue Laser	Azena Medical, LLC	2021	1

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?

The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
1 of the 26 ancestors has a recall of any class.
Of its descendants, K210350 (Azena Medical, LLC, 2021) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K152032.

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. 2020, this device’s year, is highlighted.

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 Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Frenectomy • Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Gingival incision and excision •…

Read the full statement (265 words)

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

• 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

• Treatment of aphthous ulcers.

• Vestibuloplasty

• Tissue retraction for impression

• Lesion (tumor) removal.

Laser Periodontal Procedures.

• 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, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

• Reduction of bacterial level (decontamination) and inflammation

Pain therapy

• Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K192617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192617: Gemini 810+980 Soft Tissue Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192617

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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