510(k) · Cleared

Cleared

Fotona Skinplus Laser System

K980560510(k) TraditionalCleared Mar 27, 199842-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

Fotona D.D. · GEX Powered Laser Surgical Instrument

Cleared on Mar 27, 1998 as substantially equivalent to K962902 (Medical Laser Solutions, 1997) after a 42-day review. Its family tree reaches back 2 generations to 1996.

Decided: Mar 27, 1998
Review: 42 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K953585 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK953585 Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium LaserSchwartz Electro-Optics, Inc. · 1996
1 generation backK962902 Fotona Skinlight Laser SystemMedical Laser Solutions · 1997
This deviceK980560 Fotona Skinplus Laser SystemFotona D.D. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K953585	Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser	Schwartz Electro-Optics, Inc.	1996	—
−1	K962902	Fotona Skinlight Laser System	Medical Laser Solutions	1997	—
0 (this device)	K980560	Fotona Skinplus Laser System	Fotona D.D.	1998	—

FIG. 1 — Lineage of K980560, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K970934	FDA’s K970934 is CB Erbium/2.94(TM) ER:Yag Laser Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Continuum Biomedical, Inc.	1997	—
*	K962902	Fotona Skinlight Laser System Summary page 1 …ivalent to thc Continuum Diomedical (Con-Bio) CB Erbium/2.94 Er.-YAG lascr (K270934) and is an upgrade of the the Fotona Skinlight laser systom, previously cleared under K962902. Fotona d.d. tel : +38661 15 11215 fax: +386 61 1511 §76 The CB Erbium/2.94 is cleared for skin resurfacing in t…	Medical Laser Solutions	1997	—

Also cleared against K962902: 3 other devices →

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 2 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K962902.

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.

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 Fotona SkinPlus Er:YAG surgical laser system is indicated for the cutting, ablation, vaponization, coagulation ot soft issue, and for skin resurfacing.

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/K980560 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980560: Fotona Skinplus Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980560

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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