510(k) · Cleared

Cleared

Picasso/ Picasso Lite/ Picasso Perio

K102359510(k) AbbreviatedCleared Sep 16, 2011393-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Amd Lasers, LLC · GEX Powered Laser Surgical Instrument

Cleared on Sep 16, 2011 after a 393-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.

Decided: Sep 16, 2011
Review: 393 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

20 later devices descend from it, 3 citing it directly.

This deviceK102359 Picasso/ Picasso Lite/ Picasso PerioAmd Lasers, LLC · 2011
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 · cites it directly · 4 of its ownK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
Descendant · 3 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
Descendant · 2 generations on · 3 of its ownK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013high 4 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 20 · See all

K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC · 2015 · cites it directly12descendants
K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
K122020Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013 · cites it directly4descendants
K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 3 generations on3descendants
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K102359	Picasso/ Picasso Lite/ Picasso Perio	Amd Lasers, LLC	2011	—
+1	K152939	Picasso Plus, Picasso Lite Plus	Amd Group, LLC	2015	—
+2	K193656	SkyPulse	Fotona D.O.O.	2020	—
+1	K122020	Photon Photon Plus	Zolar Technology & Mfg Co., Inc.	2013	—
+3	K202991	Fotona XPulse Pro Laser Platform	Fotona D.O.O.	2021	—
+2	K162114	Photon, Photon Plus	Zolar Technology & Mfg Co., Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	2	0
2016	1	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	2	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K102359, 2011–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152939	Picasso Plus, Picasso Lite Plus	Amd Group, LLC	2015	12
K122020	Photon Photon Plus	Zolar Technology & Mfg Co., Inc.	2013	4
K150664	NeoLas	Sheaumann Laser, Inc.	2015	1

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?

Of its descendants, K152939 (Amd Group, LLC, 2015) has gone furthest, with 12 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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 TM/Picasso Lite TM/ Picasso PerioTM isgenerally 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…

Read the full statement (232 words)

The Picasso TM/Picasso Lite TM/ Picasso PerioTM isgenerally 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 papillectomnies

* 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 debridernent (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.

Teeth Whitening Indications (Picasso Only):

* Laser assisted whiten ing/bleach ing of teeth

* Light activation for bleaching materials for teeth whitening.

In addition to the aforementioned indications of use previously cleared by the FDA, the

following indication is requested to be added:

Laser periodontal:

Picasso assisted new attachment procedure (cementum-mediated periodontal ligament

new-attachment to the root surface in the absence of long junctional epithelium).

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K102359 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102359: Picasso/ Picasso Lite/ Picasso Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102359

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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