510(k) · Cleared
ClearedEpic 980
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 16, 2020 as substantially equivalent to K192430 (Biolase, Inc., 2019) and 3 other predicates after a 90-day review. Its family tree reaches back 19 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 16, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K943450 (1995). 239 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 2 generations backK121286 EPIC 10Biolase Technology, Inc. · 2012
- 1 generation backK192430 Epic 980Biolase, Inc. · 2019
- This deviceK193486 Epic 980Biolase, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK234085 LUNE™ PureHygieneEnamel Pure · 2024
- Descendant · 2 generations on · 0 of its ownK260138 LUNE PureHygieneEnamel Pure · 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 backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 2 generations backK121286 EPIC 10Biolase Technology, Inc. · 2012
- 1 generation backK192430 Epic 980Biolase, Inc. · 2019
- This deviceK193486 Epic 980Biolase, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView 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 | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| −2 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| −1 | K192430 | Epic 980 | Biolase, Inc. | 2019 | — |
| 0 (this device) | K193486 | Epic 980 | Biolase, Inc. | 2020 | — |
| +1 | K234085 | LUNE™ PureHygiene | Enamel Pure | 2024 | — |
| +2 | K260138 | LUNE PureHygiene | Enamel Pure | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 16 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 16 | 0 |
| 2001 | 17 | 0 |
| 2002 | 22 | 0 |
| 2003 | 19 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | K192430 | Epic 980Summary page 5…d in dermatology (21 CFR 878.4810) Device Class: II Product Code: GEX III. PREDICATE DEVICES Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 D… | 2019 |
| * | K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WSummary page 5…y (21 CFR 878.4810) Device Class: II Product Code: GEX III. PREDICATE DEVICES Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445) IV. DEVICE DESCRIPT… | 2010 |
| * | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSummary page 5…Class: II Product Code: GEX III. PREDICATE DEVICES Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445) IV. DEVICE DESCRIPTION The Epic 980 diode lase… | 2011 |
| * | K152032 | ELUMI 810 + 980 Soft Tissue LaserSummary page 5…Code: GEX III. PREDICATE DEVICES Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445) IV. DEVICE DESCRIPTION The Epic 980 diode laser is a surgical and therapeutic… | 2015 |
| † | K082445 | CURATIVE980 Diode Laser | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234085 | LUNE™ PureHygiene | 2024 | 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 25 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 10 of the 239 ancestors have a recall of any class.
- Of its descendants, K234085 (Enamel Pure, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192430.
How does its category compare?
All GEX devicesGEX 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
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?
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 (282 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
• Vestibuloplasty
• Tissue retraction for impression
• Laser soft-tissue curettage
• Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket
• 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
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
• Lesion (tumor) removal
• Removal of hyperplastic tissues
• Laser assisted flap surgery
• Removal of granulation tissue
Whitening
• Light activation for bleaching materials for teeth whitening
• Laser-assisted whitening/bleaching of teeth
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/K193486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193486: Epic 980.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193486
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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