510(k) · Cleared
ClearedLUCERNA Dental Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viax Dental Lab · GEX Powered Laser Surgical Instrument
Cleared on Sep 26, 2016 as substantially equivalent to K140120 (Biolase, Inc., 2014) and 2 other predicates after a 152-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Sep 26, 2016
- Review
- 152 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K943450 (1995). 374 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 1 generation backK140120 EPIC 10Biolase, Inc. · 2014
- This deviceK161185 LUCERNA Dental LaserViax Dental Lab · 2016
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 backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 1 generation backK140120 EPIC 10Biolase, Inc. · 2014
- This deviceK161185 LUCERNA Dental LaserViax Dental Lab · 2016
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 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −2 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −1 | K140120 | EPIC 10 | Biolase, Inc. | 2014 | — |
| 0 (this device) | K161185 | LUCERNA Dental Laser | Viax Dental Lab | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 24 | 0 |
| 1997 | 29 | 0 |
| 1998 | 26 | 0 |
| 1999 | 20 | 0 |
| 2000 | 29 | 0 |
| 2001 | 33 | 0 |
| 2002 | 37 | 0 |
| 2003 | 30 | 0 |
| 2004 | 20 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 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? (3)
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 |
|---|---|---|---|
| * | K140120 | EPIC 10Summary page 7…Barrier sleeve Sterility sleeve sleeve sleeve 510(k) Pending this Number application K140120 K930210 K103667 Conclusion The subject device shares the same principle of operation as the th… | 2014 |
| * | K930210 | ACL-5500Summary page 7…Sterility sleeve sleeve sleeve 510(k) Pending this Number application K140120 K930210 K103667 Conclusion The subject device shares the same principle of operation as the three predicate devices.… | 1993 |
| * | K103667 | Sapphire ST Portable Diode LaserSummary page 7…sleeve sleeve sleeve 510(k) Pending this Number application K140120 K930210 K103667 Conclusion The subject device shares the same principle of operation as the three predicate devices. All are diode lasers… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 17 of the 374 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed: . Excision and incision biopsies . Hemostatic assistance .Treatment of apthous ulcers . Frenectomy . Frenotomy .…
Read the full statement (128 words)
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed:
. Excision and incision biopsies
. Hemostatic assistance
.Treatment of apthous ulcers
. Frenectomy
. Frenotomy
. Gingival incision and excision
. Gingivectomy
. Gingivoplasty
. Incising and draining abscesses
. Operculectomy
. Oral papillectomy
. Removal of fibromas
. Soft tissue crown lengthening
. Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
. Tissue retraction for impression
. Photo initiation of gingival barriers and dams
. Laser-assisted bleaching/whitening of teeth
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161185: LUCERNA Dental Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161185
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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