510(k) · Cleared

Cleared

Viridis Laser

K001784510(k) TraditionalCleared Sep 11, 200090-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

Cosmos Medical Technology · GEX Powered Laser Surgical Instrument

Cleared on Sep 11, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 96 later devices descend from it.

Decided: Sep 11, 2000
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

96 later devices descend from it, 2 citing it directly.

This deviceK001784 Viridis LaserCosmos Medical Technology · 2000
Descendant · cites it directly · 92 of its ownK020071 Viridis Derma LaserQuantel Medical · 2002
Descendant · 2 generations on · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
Descendant · 3 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
Descendant · 4 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
Descendant · 5 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

2002high 14 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 96 · See all

K020071Viridis Derma LaserQuantel Medical · 2002 · cites it directly92descendants
K091534Lightlas Model 532Lightmed Corp. · 2009 · 2 generations on72descendants
K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 3 generations on68descendants
K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 4 generations on46descendants
K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 5 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001784	Viridis Laser	Cosmos Medical Technology	2000	—
+1	K020071	Viridis Derma Laser	Quantel Medical	2002	—
+2	K091534	Lightlas Model 532	Lightmed Corp.	2009	—
+3	K100558	Quanta Diode Laser System	Quanta System Spa	2010	—
+4	K102755	Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…	Biolitec, Inc.	2010	—
+5	K110080	Radial-Emitting Shaped Fiber Optic Delivery System	Biolitec, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2004	2	0
2007	1	0
2009	1	0
2010	4	0
2011	4	0
2012	1	0
2013	9	0
2014	7	0
2015	3	0
2016	9	0
2017	3	0
2018	2	0
2019	4	0
2020	3	0
2021	3	0
2022	6	0
2023	3	0
2024	9	0
2025	14	0
2026	5	0

FIG. 1 — Lineage of K001784, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (96)

See all 96

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

Number	Device	Applicant	Decided	Descendants
K020071	Viridis Derma Laser	Quantel Medical	2002	92
K032397	Dual Yellow Laser, Model Dual Yellow D10B	Norseld Pty., Ltd.	2004	2

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, K020071 (Quantel Medical, 2002) has gone furthest, with 92 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.

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	—

https://510kreport.com/device/K001784 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001784: Viridis Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001784

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026