510(k) · Cleared

Cleared

Vela XL

K103654510(k) TraditionalCleared Apr 6, 2011112-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

Starmedtec GmbH · GEX Powered Laser Surgical Instrument

Cleared on Apr 6, 2011 as substantially equivalent to K070476 (Allmed Systems, Inc., 2007) after a 112-day review. Its family tree reaches back 1 generation to 2007. 14 later devices descend from it.

Decided: Apr 6, 2011
Review: 112 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K070476 (2007). 14 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK070476 Revolix 120Allmed Systems, Inc. · 2007
This deviceK103654 Vela XLStarmedtec GmbH · 2011
Descendant · cites it directly · 12 of its ownK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
Descendant · 2 generations on · 7 of its ownK211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…Gyrus Acmi, Inc. · 2021 · Recalled
Descendant · 2 generations on · 4 of its ownK221306 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc. · 2023 · Recalled
Descendant · 3 generations on · 3 of its ownK242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2024 · Recalled
Descendant · 4 generations on · 1 of its ownK261221 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2026

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2019high 4 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 14 · See all

K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2019 · cites it directly12descendants
K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc. · 2021 · 2 generations on7descendants
K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc. · 2023 · 2 generations on4descendants
K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2024 · 3 generations on3descendants
K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2026 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070476	Revolix 120	Allmed Systems, Inc.	2007	—
0 (this device)	K103654	Vela XL	Starmedtec GmbH	2011	—
+1	K183647	SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium…	Olympus Surgical Technologies America	2019	4
+2	K211401	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…	Gyrus Acmi, Inc.	2021	1
+2	K221306	SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE…	Gyrus Acmi, Inc.	2023	8
+3	K242191	SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium…	Olympus Surgical Technologies America	2024	7
+4	K261221	SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium…	Olympus Surgical Technologies America	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2021	2	0
2022	1	0
2023	1	0
2024	2	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K103654, 2007–2026Source: 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? (1)

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
*	K070476	Revolix 120 Summary page 1 …ument, surgical, powered d. Product code: GEX 3. Predicate Device: Lisa Laser Products - Revolix 120 Laser System (510(k) Number: K070476) 4. Product Description: The vela®XL is thulium laser system, which emits laser radiation with a wavelength of…	Allmed Systems, Inc.	2007	—

Also cleared against K070476: 3 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K183647	SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…	Olympus Surgical Technologies America	2019	12
K202106	Plasmage System	Brera Medical, Inc.	2022	0

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?

Its one ancestor has no recall.
Of its descendants, K183647 (Olympus Surgical Technologies America, 2019) has gone furthest, with 12 descendants of its own.
3 other devices also cite its predicate K070476.

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 vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.…

Read the full statement (555 words)

Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Strictures of Urethra and Ureter

- Bladder Neck Incisions (BNI)

- Ablation and resecetion of Bladder Tumors, Uretheral Tumors and Ureteral Tumors

- Ablation of Benign Prostatic Hyperplasia (BPH)

- Transurethral incision of prostate (TUIP)

- Holmium Laser Resection of the prostate (HoLRP)

- Holmium Laser Enucleation of the prostate (HoLEP)

- Holmium Laser Ablation of the prostate (HoLap)

- Bladder/Renal Calculi (Lithotripsy)

- Condylomas

- Lesions or external genitalia

Gastroenterology

Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Appendectomy

- Polyps

- Biopsy

- Gall Bladder Calculi (Lithotripsy)

- Biliary/Bile duct Calculi (Lithotripsy

- Ulcers

- Gastric ulcers

- Duodenal ulcers

- Non bleeding ulcers

- Pancreatitis

- Hemorrhoids

- Cholecystectomy

- Benign and malignant neoplasm

- Angiodysplasia

- Colorectal cancer

- Telangiectasias

- Telangiectasias of Osler-Weber-Renu disease

- Vascular malformation

- Gastritis

- Esophagitis

- Esophageal ulcers

- Varices

- Colitis

- Mallory-Weiss tear

- Gastric Erosions

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

- Laryngeal lesions

- Airway obstructions including carcinoma

- Polyps and granuloma

- Palliation of obstructing carcinoma of the tracheobroncial tree

Gynaecology

Open and endoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis):

- Intra-uterine treatment of sub mucous fibroids

- Benign endometrial polyps and uterine septum by incision, excision and or vessel coagulation

- Soft tissue excision procedures such as excisional conisation of the cervix

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Endonasal / sinus surgery

- Partial turbinectomy

- Polypectomy

- Dacryocystorhinostomy

- Frontal sinustomy

- Ethmoidectomy

- Maxillary antrostomy

- Functional endoscopic sinus surgery

- Lesions or tumnours (oral, nasal, glossal, pharyngeal or laryngeal)

- Tonsillectomy

- Adenoidectomy

Dermatology and Plastic Surgery

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue (hard tissue) including:

- Basal Cell Carcinomas

- Lesion of skin and subcutaneous tissue

- Skin tags

- Plantar warts

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Cholecystectomy

- Lysis of adhesion

- Appendectomy

- Biopsy

- Skin incision

- Tissue dissection

- Excision of external tumnours and lesions

- Complete or partial resection of internal organs, tumnours, lesions

- Mastectomy

- Hepatectomy

- Pancreatectomy

- Splenectomy

- Thyroidectomy

- Parathyroidectomy

- Herniorrhaphy

- Tonsillectomy

- Lymphadenectomy

- Partial nephrectomy

- Pilonidal Cystectomy

- Resection of lipoma

- Debridement of decubitus ulcer

- Hemorrhoids

- Debridement of statis ulcer

Arthroscopy

Arthroscopic/orthopaedic surgery (excision, ablation, and coagulation of soft and cartilaginous (hard) tissue):

Ablation of soft and cartilaginous (hard) tissue in minimal invasive spinal surgery including

- Percutaneous laser disc decompressionldisectomy

- Foraminoplasty

- Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery

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/K103654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103654: Vela XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103654

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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