510(k) · Cleared
ClearedEPIC 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2012 as substantially equivalent to K083069 (Biolase Technology, Inc., 2008) and 4 other predicates after a 151-day review. Its family tree reaches back 17 generations to 1995. 31 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K943450 (1995). 228 ancestors in all, the oldest K800617 (1980). 31 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK082938 EzlaseBiolase Technology, Inc. · 2008
- This deviceK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · cites it directly · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 2 generations on · 12 of its ownK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 6 of its ownK210367 D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 5 of its ownK192430 Epic 980Biolase, Inc. · 2019
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK082938 EzlaseBiolase Technology, Inc. · 2008
- This deviceK121286 EPIC 10Biolase Technology, Inc. · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K170500SIROLaser Advance+Dentsply Sirona · 2017 · cites it directly21descendants
- K180044SIROLaser BlueDentsply Sirona · 2018 · 2 generations on12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 2 generations on6descendants
- K192430Epic 980Biolase, Inc. · 2019 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| 0 (this device) | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +1 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +2 | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K192430 | Epic 980 | Biolase, Inc. | 2019 | — |
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 | 18 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K083069 | Ezlase 10WSummary page 1…nd in dermatology; and infrared lamp Regulatory Class: 11 Product Code: GEX, ILY 3. PREDICATE DEVICES * ezlaseT~M by Biolase Technology, Inc. K083069, K083595, K061898, and K082938 * iLasem by Biolase Technology, Inc. K093852 Pagel1of 4 ===… | 2008 |
| * | K083595 | EzlaseSummary page 1…matology; and infrared lamp Regulatory Class: 11 Product Code: GEX, ILY 3. PREDICATE DEVICES * ezlaseT~M by Biolase Technology, Inc. K083069, K083595, K061898, and K082938 * iLasem by Biolase Technology, Inc. K093852 Pagel1of 4 === Page 2 ==… | 2009 |
| * | K061898 | EzlaseSummary page 1…and infrared lamp Regulatory Class: 11 Product Code: GEX, ILY 3. PREDICATE DEVICES * ezlaseT~M by Biolase Technology, Inc. K083069, K083595, K061898, and K082938 * iLasem by Biolase Technology, Inc. K093852 Pagel1of 4… | 2007 |
| * | K082938 | EzlaseSummary page 1…lamp Regulatory Class: 11 Product Code: GEX, ILY 3. PREDICATE DEVICES * ezlaseT~M by Biolase Technology, Inc. K083069, K083595, K061898, and K082938 * iLasem by Biolase Technology, Inc. K093852 Pagel1of 4… | 2008 |
| * | K093852 | Ezlase 3 Laser SystemSummary page 1…Code: GEX, ILY 3. PREDICATE DEVICES * ezlaseT~M by Biolase Technology, Inc. K083069, K083595, K061898, and K082938 * iLasem by Biolase Technology, Inc. K093852 Pagel1of 4… | 2010 |
What descends from it? (31)
See all 314 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 17 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 10 of the 228 ancestors have a recall of any class.
- Of its descendants, K170500 (Dentsply Sirona, 2017) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K083069.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
1. 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 (247 words)
1. 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 refraction for impression
2. Laser Periodontal Procedures
* 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 ahd necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
3. Witening
Light activation for bleaching materials for teeth whitenifivisiof SignlOfl)
Laser-assisted whitening/bleaching of teeth
4. Pain Therapy
Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffniess, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121286: EPIC 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121286
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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