510(k) · Cleared
ClearedGemini 2 810+980 Soft Tissue Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azena Medical, LLC · NVK Laser, Dental, Soft Tissue
Cleared on Nov 18, 2021 as substantially equivalent to K192617 (Azena Medical, LLC, 2020) and 1 other predicate after a 283-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Nov 18, 2021
- Review
- 283 days
- Class
- Class II
- Product code
- NVK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 205 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 2 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 1 generation backK163128 Epic ProBiolase, Inc. · 2017
- This deviceK210350 Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK260765 Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC · 2026
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 4 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 3 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 2 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 1 generation backK163128 Epic ProBiolase, Inc. · 2017
- This deviceK210350 Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −4 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −3 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| −2 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| −1 | K163128 | Epic Pro | Biolase, Inc. | 2017 | — |
| 0 (this device) | K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021 | — |
| +1 | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 15 | 0 |
| 2001 | 14 | 0 |
| 2002 | 17 | 0 |
| 2003 | 14 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 NVK? 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 NVK device
- #1 K210367 D-Laser Blue, D-Laser 16score 20.7 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192617 | Gemini 810+980 Soft Tissue LaserSummary page 6…vice: Company: Azena Medical, LLC Device: Gemini 810+980 Diode laser 510(k): K192617 Date Cleared: February 20, 2020 Reference Predicate Device: Company:… | 2020 |
| * | K163128 | Epic ProSummary page 6…Company: Biolase Technology, Inc. Device: Epic Pro Diode Laser System 510(k): K163128 Date Cleared: January 11, 2017 4. A description of the device that is the subject of the 510(k),… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | 2026 | 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?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 8 of the 205 ancestors have a recall of any class.
- Of its descendants, K260765 (Azena Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NVK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVK
139in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVK
1in 2024
MAUDE reports naming product code NVK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 4 | 277 | 0 | 0 |
| 2022 | 5 | 139 | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
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/K210350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210350: Gemini 2 810+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/K210350
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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