510(k) · Cleared

Cleared

Vectra Plus Laser System and Accessories

K082230510(k) TraditionalCleared Feb 3, 2010545-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

Xintec Corporation · GEX Powered Laser Surgical Instrument

Cleared on Feb 3, 2010 as substantially equivalent to K024088 (Biolitec, Inc., 2003) and 19 other predicates after a 545-day review. Its family tree reaches back 17 generations to 1995. 112 later devices descend from it.

Decided: Feb 3, 2010
Review: 545 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 20

Its longest line of descent runs back 17 generations to K943450 (1995). 330 ancestors in all, the oldest K771218 (1978). 112 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
13 generations between
3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
This deviceK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Descendant · 4 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016

Show all 17 generations

Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
This deviceK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2011high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 112 · See all

K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 4 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−17	K943450	Arthrocare Arthroscopic Electrosurgery System Model 970	Arthrocare Corp.	1995	—
−16	K961069	Arthrocare Urologic Multi-Electrode Electrosurgery System	Arthrocare Corp.	1996	—
−15	K962445	Arthrocare Dental Electrosurgery System	Arthrocare Corp.	1996	—
−14	K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	—
−13	K973478	Arthrocare Sinus Electrosurgery System	Arthrocare Corp.	1998	—
−12	K981870	Visage Cosmetic Surgery System	Arthrocare Corp.	1998	—
−11	K000944	Thermage Thermacool System	Thermage, Inc.	2000	—
−10	K013034	Modification to: Thermacool Iia	Thermage, Inc.	2001	—
−9	K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	—
−8	K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	—
−7	K030142	Thermacool TC System	Thermage, Inc.	2003	—
−6	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—
−5	K041959	Polaris DS/Comet	Syneron Medical, Ltd.	2004	—
−4	K053540	Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…	Intermedic Arfran, SA	2006	—
−3	K071295	100W Ceralas D 980NM Diode Laser	Biolitec, Inc.	2007	—
−2	K072106	150W Ceralas D 980NM Diode Laser	Biolitec, Inc.	2007	—
−1	K083682	180W Cerelas D 980NM Diode Laser, Model D180	Biolitec, Inc.	2009	—
0 (this device)	K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	—
+1	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+2	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+3	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers, Ltd.	2014	—
+4	K153671	Family of CoolGlide Aesthetic Lasers	Cutera, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1980	1	0
1981	1	0
1982	1	0
1985	1	0
1988	1	0
1989	2	0
1990	4	0
1991	7	0
1992	5	0
1993	12	0
1994	18	0
1995	20	0
1996	21	0
1997	26	0
1998	22	0
1999	18	0
2000	27	0
2001	28	0
2002	33	0
2003	27	0
2004	17	0
2005	10	0
2006	4	0
2007	1	0
2008	4	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	3	0
2015	5	0
2016	1	0
2017	4	0
2018	8	0
2019	6	0
2020	11	0
2021	8	0
2022	18	0
2023	9	0
2024	13	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K082230, 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? (20)

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
*	K024088	Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25 Summary page 1 …: Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 9…	Biolitec, Inc.	2003	—
*	K032863	Ceralas D 980 Diode Laser System, Models D15, D25, D50 Summary page 1 …Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode…	Biolitec, Inc.	2004	—
*	K050824	100W Ceralas D 980 Laser System, Model D100 Summary page 1 …gical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and…	Biolitec, Inc.	2005	—
*	K071295	100W Ceralas D 980NM Diode Laser Summary page 1 …e Laser System, 21 C.F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE…	Biolitec, Inc.	2007	—
*	K072106	150W Ceralas D 980NM Diode Laser Summary page 1 …stem, 21 C.F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories…	Biolitec, Inc.	2007	—
*	K072682	50W Ceralas D 1950NM Diode Laser Summary page 1 …F.R. 878.4810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k)…	Biolitec, Inc.	2008	—
*	K073063	15W Ceralas D 1470NM Diode Laser Summary page 1 …810, Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$…	Biolitec, Inc.	2008	—
*	K082225	15W Ceralas D 1470NM Diode Laser, Model D1470 Cleared while this submission was under review Summary page 1 …Product Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871;…	Biolitec, Inc.	2008	—
*	K083682	180W Cerelas D 980NM Diode Laser, Model D180 Cleared while this submission was under review Summary page 1 …Code GEX Predicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114…	Biolitec, Inc.	2009	—
*	K090164	Ceralas Multiwavelength 980/1470NM Diode Laser Cleared while this submission was under review Summary page 1 …redicate Devices: Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599…	Biolitec, Inc.	2009	—
*	K060114	Vectra Laser System Summary page 1 …#K050824; #K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser…	Xintec Corporation, Dba,	2006	—
*	K902871	Optilite Fiberoptic Delivery Systems Summary page 1 …K071295; #K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121)…	Xintec Corporation	1990	—
*	K910114	Optilite (TM) Fiberoptic Delivery Systems and Acce Summary page 1 …K072 106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended…	Xintec Corporation	1991	—
*	K923599	Optilite Fiberoptic Delivery Systems Summary page 1 …K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indic…	Xintec Corporation	1993	—
*	K944474	Optilite V Fiberoptic Accessories Summary page 1 …K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for…	Xintec Corporation	1994	—
*	K944965	Optilite VI Fiberoptic Accessories Summary page 1 …K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for Use: ===…	Xintec Corporation	1995	—
*	K944704	Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn and… Summary page 1 …K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for Use: === Page 2 ==…	Xintec Corporation	1995	—
*	K951760	Optilite Viii Laser Surgery Accessories Summary page 1 …K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for Use: The…	Xintec Corporation	1995	—
*	K992866	Optilite IX Laser Surgery Accessories Summary page 1 …Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for Use: The device is…	Convergent Laser Technologies	1999	2
*	K080121	Cynosure Smartlipo Multiwavlength Laser Summary page 1 …ptiLITE Accessories (5 10(k) #K0601 14$ #K902871; #K91 0114; #K923599; #K944474; #K944965; #K944704; #K95 1760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121) Intended Use/Indications for Use: The device is intended for delivery of laser light to soft tissue in th…	Cynosure, Inc.	2008	—

Also cleared against K024088: 2 other devices →

What descends from it? (112)

See all 112

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101916	Joule Multi-Platform System	Sciton, Inc	2011	111

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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
16 of the 330 ancestors have a recall of any class.
Of its descendants, K101916 (Sciton, Inc, 2011) has gone furthest, with 111 descendants of its own.
2 other devices also cite its predicate K024088.

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. 2010, 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 device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes. The device is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, genecology…

Read the full statement (669 words)

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

Removal of benign lesions from the ear, nose and throat, e.g., turbinectomy

Excision and vaporization of vocal cord nodules & polyps, e.g., tonselectomy, uvelaplasty

Incision and excision of carcinoma in situ, e.g., bronchoscopy

Ablation and vaporization of hyperkeratosis

Excision of carcinoma of the larynx

Laryngeal papillomectomy

Excision and vaporization of herpes simplex I and H1

Neck dissection

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

Menisectomy

Synovectomy

Chondromalacia

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding

Excision and vaporization of colorectal carcinoma

Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemnostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion, Examples include:

Matrixectomny

Excision of neuromas

Excision of periungual and subungual warts

Excision of plantar warts and keloids

Liver resection

Excision of cutaneous lesions

Hemorrhoidectomy

Appendectomy

Debridement of decubitus ulcers

Hepatobiliary tumors

Mastectomy

Dermabrasion

Vaporization and hemostasis of capillary hemangioma

Excision, vaporization and hemnostasis of abdominal tumors

Excision, vaporization and hemostasis of rectal pathology

Pilonidal cystectomy

Hemiorapphy

Adhesiolysis

Parathyroidectomny

Laparoscopic cholecystectomay

Thyroidectomy

Resection of organs

Debridemnent of wounds

Photocoagulation of teleangectasia of the legs and face

Photocoagulation of vascular lesions of the face and extremities

Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux

Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological, including BPHlprostatic, tissues. Examples include:

Vaporization of uretheral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia

Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:

Endometrial ablation

Excision or vaporization of condylomata aCLuminata

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue Examples include: Hemeostasis in conjunction with menigiomnas

Cardiac Surgery

Hemnostasis and coagulation of soft tissue, including cardiac tissue

Pulmonary Surgery

H'emostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture

Benign and malignant pulmonary obstruction

Endoscopic pulmonary applications

Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aplithous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux associated with varicose veins and varicosities

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/K082230 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082230: Vectra Plus Laser System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082230

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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