510(k) · Cleared
ClearedPicasso Plus, Picasso Lite Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amd Group, LLC · GEX Powered Laser Surgical Instrument
Cleared on Nov 25, 2015 as substantially equivalent to K083142 (Amd Lasers, LLC, 2009) and 1 other predicate after a 51-day review. Its family tree reaches back 5 generations to 2001. 12 later devices descend from it.
- Decided
- Nov 25, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011041 (2001). 12 ancestors in all, the oldest K993285 (1999). 12 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 4 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 3 generations backK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- 2 generations backK062071 Prometey, Model G1-03Spectrum International · 2006
- 1 generation backK083142 Picasso Laser SystemAmd Lasers, LLC · 2009
- This deviceK152939 Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK230274 Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D…Gigaalaser Company, Ltd. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
- K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023 · 2 generations on2descendants
- K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −4 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −3 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| −2 | K062071 | Prometey, Model G1-03 | Spectrum International | 2006 | — |
| −1 | K083142 | Picasso Laser System | Amd Lasers, LLC | 2009 | — |
| 0 (this device) | K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | 2015 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +2 | K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023 | — |
| +2 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS… | Gigaalaser Company, Ltd. | 2025 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083142 | Picasso Laser SystemSummary page 5…Plus and Picasso Lite Plus V. PREDICATE DEVICE Device Trade Name: Picasso and Picasso Lite Device Company: AMO LASERS 51 O(k) Numbers: K083142 andK102359 VI. DEVICE DESCRIPTION The Picasso line of soft tissue dental lasers is designed for a wide variety of or… | 2009 |
| * | K102359 | Picasso/ Picasso Lite/ Picasso PerioSummary page 5…icasso Lite Plus V. PREDICATE DEVICE Device Trade Name: Picasso and Picasso Lite Device Company: AMO LASERS 51 O(k) Numbers: K083142 andK102359 VI. DEVICE DESCRIPTION The Picasso line of soft tissue dental lasers is designed for a wide variety of oral… | 2011 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193656 | SkyPulse | 2020 | 11 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K193656 (Fotona D.O.O., 2020) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K083142.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional biopsies; Exposure of unerupted teeth; Fibroma removal; Frenectomy and frenotomy; Implant recovery; Incision and drainage of abscess…
Read the full statement (188 words)
The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional 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; and Vestibuloplasty.
Laser Periodontal Procedures, including: Sulcular debridement (curettage, 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); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.
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/K152939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152939: Picasso Plus, Picasso Lite Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152939
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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