510(k) · Cleared
ClearedPicasso Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amd Lasers, LLC · GEX Powered Laser Surgical Instrument
Cleared on Mar 13, 2009 as substantially equivalent to K030539 (Biolase Technology, Inc., 2003) and 5 other predicates after a 141-day review. Its family tree reaches back 4 generations to 2001. 16 later devices descend from it.
- Decided
- Mar 13, 2009
- Review
- 141 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K011041 (2001). 10 ancestors in all, the oldest K993285 (1999). 16 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 3 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 2 generations backK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- 1 generation backK062071 Prometey, Model G1-03Spectrum International · 2006
- This deviceK083142 Picasso Laser SystemAmd Lasers, LLC · 2009
- Descendant · cites it directly · 12 of its ownK152939 Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 3 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 3 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK230274 Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015 · cites it directly12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 3 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 3 generations on2descendants
- K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −3 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −2 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| −1 | K062071 | Prometey, Model G1-03 | Spectrum International | 2006 | — |
| 0 (this device) | K083142 | Picasso Laser System | Amd Lasers, LLC | 2009 | — |
| +1 | K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | 2015 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +3 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +3 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +3 | K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K030539 | LasersmileSummary page 1…Panel: General & Plastic Surgery 3. Predicate Devices The Picasso"' is substantially equivalent to: *Biolase* LaserSmile"' cleared in K03 0539 *Softbase"'G2, by Zap Lasers"-, LLC cleared in K02 1227 *Biolase~ Twilite"cleared in K003385… | 2003 |
| * | K021227 | Softlase G2-Surgical Diode Laser SystemSummary page 1…es The Picasso"' is substantially equivalent to: *Biolase* LaserSmile"' cleared in K03 0539 *Softbase"'G2, by Zap Lasers"-, LLC cleared in K02 1227 *Biolase~ Twilite"cleared in K003385 *SoftLase"'by Zap Lasers"', LLC cleared in K003 440 *Bio… | 2002 |
| * | K003385 | Twilite, Twilite WhiteSummary page 1…t to: *Biolase* LaserSmile"' cleared in K03 0539 *Softbase"'G2, by Zap Lasers"-, LLC cleared in K02 1227 *Biolase~ Twilite"cleared in K003385 *SoftLase"'by Zap Lasers"', LLC cleared in K003 440 *Biolase~ DioLase Plus"' *Odyssey 2.4G, b… | 2001 |
| * | K003440 | Softlase - Surgical Diode Laser SystemSummary page 1…*Softbase"'G2, by Zap Lasers"-, LLC cleared in K02 1227 *Biolase~ Twilite"cleared in K003385 *SoftLase"'by Zap Lasers"', LLC cleared in K003 440 *Biolase~ DioLase Plus"' *Odyssey 2.4G, by Ivoclar Vivadent cleared in K050453 *Prometey, by… | 2001 |
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 1…in K003385 *SoftLase"'by Zap Lasers"', LLC cleared in K003 440 *Biolase~ DioLase Plus"' *Odyssey 2.4G, by Ivoclar Vivadent cleared in K050453 *Prometey, by Spectrum Lasers cleared in K06207 1 4. Device Description The Picasso"' is a diode laser with… | 2005 |
| * | K062071 | Prometey, Model G1-03Summary page 1…d in K003 440 *Biolase~ DioLase Plus"' *Odyssey 2.4G, by Ivoclar Vivadent cleared in K050453 *Prometey, by Spectrum Lasers cleared in K06207 1 4. Device Description The Picasso"' is a diode laser with an 8 10 nrn wavelength.… | 2006 |
| * | — | Biolase DioLase Plus Named without a submission number |
What descends from it? (16)
See all 163 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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K152939 (Amd Group, LLC, 2015) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K030539.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Picasso is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: · Gingival troughing for crown impressions · Gingiveotomy · Gingivoplasty · Gigival incision and excision · Hemostasis and coagulation · Excisional and micisional biopsies · Exposure of unerupted teeth · Fibroma removal · Frenectomy and frenotomy · Implant recovery · Incision and drainage of abscess · Leukoplakia…
Read the full statement (200 words)
The Picasso is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
· Gingival troughing for crown impressions
· Gingiveotomy
· Gingivoplasty
· Gigival incision and excision
· Hemostasis and coagulation
· Excisional and micisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Frenectomy and frenotomy
· 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
Laser periodontal procedures, including:
* 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).
· Laser soft tissue curettage
* Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket.
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
Tooth Whitening Indications:
· Laser assisted whiteninglbleaching of teeth.
· Light activation for bleaching materials for teeth whitening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083142: Picasso Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083142
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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