510(k) · Cleared
ClearedELUMI 810 + 980 Soft Tissue Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azena Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on Sep 16, 2015 as substantially equivalent to K100474 (Quicklase Limited, 2010) after a 56-day review. Its family tree reaches back 7 generations to 1992. 7 later devices descend from it.
- Decided
- Sep 16, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922901 (1992). 25 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 6 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 5 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 4 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 3 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 2 generations backK063384 Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc. · 2007
- 1 generation backK100474 Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980…Quicklase Limited · 2010
- This deviceK152032 ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015
- Descendant · cites it directly · 2 of its ownK193486 Epic 980Biolase, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK192617 Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK234085 LUNE™ PureHygieneEnamel Pure · 2024
- Descendant · 2 generations on · 1 of its ownK210350 Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK260138 LUNE PureHygieneEnamel Pure · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193486Epic 980Biolase, Inc. · 2020 · cites it directly2descendants
- K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020 · cites it directly2descendants
- K234085LUNE™ PureHygieneEnamel Pure · 2024 · 2 generations on1descendant
- K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021 · 2 generations on1descendant
- K260138LUNE PureHygieneEnamel Pure · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −6 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −5 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −4 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −3 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −2 | K063384 | Diodent Micro Dental Laser System, Models 810 and 980 | Hoya Conbio, Inc. | 2007 | — |
| −1 | K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model… | Quicklase Limited | 2010 | — |
| 0 (this device) | K152032 | ELUMI 810 + 980 Soft Tissue Laser | Azena Medical, LLC | 2015 | — |
| +1 | K193486 | Epic 980 | Biolase, Inc. | 2020 | — |
| +1 | K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | 2020 | — |
| +2 | K234085 | LUNE™ PureHygiene | Enamel Pure | 2024 | — |
| +2 | K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021 | — |
| +3 | K260138 | LUNE PureHygiene | Enamel Pure | 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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WSummary page 6…claimed: Predicate Device: Company: QuickLase Limited Device: QuickLase DUAL+ 510(k): K100474 Date Cleared: March 16, 2010 4. A description of the device that is the subject of the 510(k), including a… | 2010 |
| † | K102639 | SL3 | 2010 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K193486 (Biolase, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K100474.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 indications for use are identical to those of the previously cleared Predicate Device. The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue. The following are the oropharyngeal indications for use: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Gingivoplasty • Hemostasis and coagulation • Incision and drainage of…
Read the full statement (234 words)
The indications for use are identical to those of the previously cleared Predicate Device. The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.
The following are the oropharyngeal indications for use:
• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Gingivoplasty
• Hemostasis and coagulation
• Incision and drainage of abscess
• Operculectomy
• Pulpotomy
• Reduction of gingival hypertrophy
• Soft tissue crown lengthening
• Vestibuloplasty
• Laser Soft Tissue Curettage
• Tissue retraction
• Frenectomy and Frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingival incision and excision
• Implant recovery
• Leukoplakia
• Oral papillectomnies
• Pulpotomy as an adjunct to root canal therapy
• Reduction of bacterial level (decontamination) and inflammation
• Treatment of aphthous ulcers
• Lesion (tumor) removal
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Removal of Diseased, Infected, Inflamed and necrotic 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 necrotic, 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)
• 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/K152032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152032: ELUMI 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/K152032
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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