510(k) · Cleared

Cleared

Velure Family of Diode Lasers and Delivery Device Accessories

K063396510(k) TraditionalCleared Jan 17, 200769-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

Lasering S.R.L. · GEX Powered Laser Surgical Instrument

Cleared on Jan 17, 2007 as substantially equivalent to K042496 (Adept Medical Concepts, 2004) and 1 other predicate after a 69-day review. Its family tree reaches back 14 generations to 1995. 22 later devices descend from it.

Decided: Jan 17, 2007
Review: 69 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 14 generations to K943450 (1995). 175 ancestors in all, the oldest K800617 (1980). 22 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
10 generations between
3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
This deviceK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
Descendant · cites it directly · 20 of its ownK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
Descendant · 2 generations on · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
Descendant · cites it directly · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
Descendant · 2 generations on · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
Descendant · 3 generations on · 3 of its ownK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016

Show all 14 generations

Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
This deviceK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010high 4 (2019) · low 0 (2011)2026

Most influential descendants

Showing 5 of 22 · See all

K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010 · cites it directly20descendants
K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · 2 generations on9descendants
K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · cites it directly7descendants
K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · 2 generations on6descendants
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−14	K943450	Arthrocare Arthroscopic Electrosurgery System Model 970	Arthrocare Corp.	1995	—
−13	K961069	Arthrocare Urologic Multi-Electrode Electrosurgery System	Arthrocare Corp.	1996	—
−12	K962445	Arthrocare Dental Electrosurgery System	Arthrocare Corp.	1996	—
−11	K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	—
−10	K973478	Arthrocare Sinus Electrosurgery System	Arthrocare Corp.	1998	—
−9	K981870	Visage Cosmetic Surgery System	Arthrocare Corp.	1998	—
−8	K000944	Thermage Thermacool System	Thermage, Inc.	2000	—
−7	K013034	Modification to: Thermacool Iia	Thermage, Inc.	2001	—
−6	K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	—
−5	K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	—
−4	K030142	Thermacool TC System	Thermage, Inc.	2003	—
−3	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—
−2	K041959	Polaris DS/Comet	Syneron Medical, Ltd.	2004	—
−1	K053540	Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…	Intermedic Arfran, SA	2006	—
0 (this device)	K063396	Velure Family of Diode Lasers and Delivery Device Accessories	Lasering S.R.L.	2007	—
+1	K100143	Pilot Diode Laser, Model 002-00139	CAO Group, Inc.	2010	—
+2	K123443	Precise SHP Diode Laser	CAO Group, Inc.	2013	—
+1	K102036	Doctor Surgery Diode Lasers Family	Lambda S.P.A.	2010	—
+2	K122567	Joule 810/940/980 Multi-Platform System	Sciton, Inc	2013	—
+3	K162114	Photon, Photon Plus	Zolar Technology & Mfg Co., Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1985	1	0
1988	1	0
1989	1	0
1990	2	0
1991	3	0
1992	3	0
1993	6	0
1994	9	0
1995	13	0
1996	15	0
1997	20	0
1998	11	0
1999	7	0
2000	14	0
2001	12	0
2002	19	0
2003	12	0
2004	7	0
2005	4	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2013	3	0
2014	2	0
2015	1	0
2016	2	0
2017	1	0
2018	1	0
2019	4	0
2020	1	0
2021	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K063396, 1995–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K042496	Adept Ultralite 532 Laser Summary page 1 …evices: The Velure Family of Diode Lasers and deliver device accessories are substantially equivalent to the predicate devices Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540. 4. Device Description: The Velure Family of Diode Lasers emit a beam of co…	Adept Medical Concepts	2004	—
*	K053540	Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are… Summary page 1 …s and deliver device accessories are substantially equivalent to the predicate devices Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540. 4. Device Description: The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse…	Intermedic Arfran, SA	2006	—

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K100143	Pilot Diode Laser, Model 002-00139	CAO Group, Inc.	2010	20
K102036	Doctor Surgery Diode Lasers Family	Lambda S.P.A.	2010	7

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 12 years and passes through 5 companies; a new generation was cleared every 9 months on median.
6 of the 175 ancestors have a recall of any class.
Of its descendants, K100143 (CAO Group, Inc., 2010) has gone furthest, with 20 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. 2007, 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 Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.

Velure S5

532nm (Green) Diode Laser

Applications:

Vascular Lesions

Pigmented Lesions

Velure S8115, Velure S8/30 and Velure S800

808nm Diode Laser

Applications:

Vascular Lesions

Unwanted Hair Removal

Velure S9/15, Velure S9/30

980nm Diode Laser

Applications:

Surgical

Cut and coagulate

General Surgery

GYN

ENT

Neuro

Urgology

Velure S917D and Velure S9/15D

980nm Diode Laser

Applications:

Oral and Periodontal Surgery

Bleaching (tooth whitening)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063396 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063396: Velure Family of Diode Lasers and Delivery Device Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063396

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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

Velure Family of Diode Lasers and Delivery Device Accessories

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (2)

What descends from it? (22)

Has anything in its family been recalled? (0 Class I)

What does this lineage say?

How does its category compare?

What is it indicated for?

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