510(k) · Cleared
ClearedDental Diode Laser Device (Laser-Pen)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Kevin Peter Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 18, 2026 as substantially equivalent to K200693 (Hulaser, Inc., 2020) and 1 other predicate after a 171-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Sep 18, 2026
- Review
- 171 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K943450 (1995). 267 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- 2 generations backK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- 1 generation backK200693 K2 MobileHulaser, Inc. · 2020
- This deviceK261047 Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 6 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 5 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 4 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 3 generations backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- 2 generations backK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- 1 generation backK200693 K2 MobileHulaser, Inc. · 2020
- This deviceK261047 Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −6 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −5 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| −4 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| −3 | K122020 | Photon Photon Plus | Zolar Technology & Mfg Co., Inc. | 2013 | — |
| −2 | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| −1 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
| 0 (this device) | K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 24 | 0 |
| 1998 | 16 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 19 | 0 |
| 2002 | 24 | 0 |
| 2003 | 19 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K200693 | K2 MobileSummary page 5…ice Class: Class II Review Panel: General & Plastic Surgery Submitter/510(k) Holder: HULASER, Inc. Clearance: K200693 Predicate Device 2: Trade Name: Epic 980 Device Name: Dental Diode Laser Device Classific… | 2020 |
| * | K192430 | Epic 980Summary page 6…s: Class II Review Panel: General & Plastic Surgery Submitter/510(k) Holder: Biolase, Inc. Clearance: K192430 Device Description: The Dental Diode Laser Device (Model: Laser-Pen) emits non-ionizing laser radiation via a semiconductor las… | 2019 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 267 ancestors have a recall of any class.
- 1 other device also cites its predicate K200693.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy Periodontal procedures: Sulcular debridement Implant procedures: Implant recovery Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma…
Read the full statement (136 words)
Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows:
Endodontic procedures:
Pulpotomy, Root canal therapy
Periodontal procedures:
Sulcular debridement
Implant procedures:
Implant recovery
Surgery procedures:
Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy,Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty
Other procedures:
Gingival troughing, Hemostasis and coagulation Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relation 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/K261047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261047: Dental Diode Laser Device (Laser-Pen).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261047
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026