510(k) · Cleared
ClearedPrometey, Model G1-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum International · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2006 as substantially equivalent to K050453 (Ivoclar Vivadent, Inc., 2005) and 2 other predicates after a 69-day review. Its family tree reaches back 3 generations to 2001. 17 later devices descend from it.
- Decided
- Sep 28, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011041 (2001). 9 ancestors in all, the oldest K993285 (1999). 17 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 2 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 1 generation backK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- This deviceK062071 Prometey, Model G1-03Spectrum International · 2006
- Descendant · cites it directly · 16 of its ownK083142 Picasso Laser SystemAmd Lasers, LLC · 2009
- Descendant · 2 generations on · 12 of its ownK152939 Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 4 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 4 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K083142Picasso Laser SystemAmd Lasers, LLC · 2009 · cites it directly16descendants
- K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015 · 2 generations on12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 4 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −2 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −1 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| 0 (this device) | K062071 | Prometey, Model G1-03 | Spectrum International | 2006 | — |
| +1 | K083142 | Picasso Laser System | Amd Lasers, LLC | 2009 | — |
| +2 | K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | 2015 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +4 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +4 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 1…Laser instrument, Surgical, Powered - Product code: GEX Legally Marketed Predicate Devices for Substantial Equivalence: - K050453 Odyssey 2.4G by Ivoclar Vivodent, Inc. - K030539 LaserSmile by BioLase Technology, Inc. -… | 2005 |
| * | K030539 | LasersmileSummary page 1…GEX Legally Marketed Predicate Devices for Substantial Equivalence: - K050453 Odyssey 2.4G by Ivoclar Vivodent, Inc. - K030539 LaserSmile by BioLase Technology, Inc. - K021227 SoftLase by ZAP Lasers, LLC Descript… | 2003 |
| * | K021227 | Softlase G2-Surgical Diode Laser SystemSummary page 1…Substantial Equivalence: - K050453 Odyssey 2.4G by Ivoclar Vivodent, Inc. - K030539 LaserSmile by BioLase Technology, Inc. - K021227 SoftLase by ZAP Lasers, LLC Description of Submitted Device: The PROMETEY Tm diode laser system is a de… | 2002 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083142 | Picasso Laser System | 2009 | 16 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K083142 (Amd Lasers, LLC, 2009) has gone furthest, with 16 descendants of its own.
- 8 other devices also cite its predicate K050453.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure…
Read the full statement (150 words)
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.
Laser Periodontal Procedures, including:
Laser soft tissue curettage, 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).
Teeth Whitening Procedures, including:
Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching 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/K062071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062071: Prometey, Model G1-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062071
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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