510(k) · Cleared
Recalled · Class II · 2024SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 27, 2023 as substantially equivalent to K211401 (Gyrus Acmi, Inc., 2021) and 1 other predicate after a 267-day review. Its family tree reaches back 10 generations to 1994. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 27, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 10 generations to K936109 (1994). 36 ancestors in all, the oldest K853620 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations between
- 3 generations backK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
- 2 generations backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
- 1 generation backK211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…Gyrus Acmi, Inc. · 2021 · Recalled
- This deviceK221306 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK261221 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2026
- Descendant · 3 generations on · 0 of its ownK262877 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2026
- Descendant · 2 generations on · 0 of its ownK250504 Leonardo DusterCeramoptec GmbH · 2025
Show all 10 generations
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 4 generations backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
- 3 generations backK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
- 2 generations backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
- 1 generation backK211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…Gyrus Acmi, Inc. · 2021 · Recalled
- This deviceK221306 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2024 · cites it directly3descendants
- K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2026 · 2 generations on1descendant
- K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2026 · 3 generations on0descendants
- K250504Leonardo DusterCeramoptec GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −9 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −7 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −6 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −5 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −4 | K140388 | Lumenis Pulse 120H | Lumenis, Ltd. | 2014 | — |
| −3 | K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | Lumenis, Ltd. | 2017 | 1 |
| −2 | K183647 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium… | Olympus Surgical Technologies America | 2019 | 4 |
| −1 | K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium… | Gyrus Acmi, Inc. | 2021 | 1 |
| 0 (this device) | K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE… | Gyrus Acmi, Inc. | 2023 | — |
| +1 | K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium… | Olympus Surgical Technologies America | 2024 | 7 |
| +2 | K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium… | Olympus Surgical Technologies America | 2026 | — |
| +3 | K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium… | Olympus Surgical Technologies America | 2026 | — |
| +2 | K250504 | Leonardo Duster | Ceramoptec GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Summary page 5…GEX Classification: Class II Review Panel: Gastroenterology/Urology Predicate Devices SOLTIVE Laser Systems K211401, K183647 48… | 2021 |
| * | K183647 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Summary page 5…assification: Class II Review Panel: Gastroenterology/Urology Predicate Devices SOLTIVE Laser Systems K211401, K183647 48… | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed… | 2024 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2024 | Class II | Z-0135-2025 | Under Investigation by firm | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the… |
| Aug 13, 2024 | Class II | Z-0134-2025 | Under Investigation by firm | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the… |
| May 31, 2024 | Class II | Z-2505-2024 | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. |
| May 31, 2024 | Class II | Z-2504-2024 | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. |
| May 31, 2024 | Class II | Z-2506-2024 | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. |
| Jan 29, 2024 | Class II | Z-1384-2024 | Under Investigation by firm | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. |
| Jan 29, 2024 | Class II | Z-1385-2024 | Under Investigation by firm | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. |
| Dec 4, 2023 | Class II | Z-0718-2024 | Under Investigation by firm | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient). |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 36 ancestors have a recall of any class.
- Of its descendants, K242191 (Olympus Surgical Technologies America, 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K211401.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology • Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]…
Read the full statement (284 words)
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology
• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] • Laser Resection of the Prostrate (LRP) • Laser Enucleation of the Prostate (LEP) • Laser Ablation of the Prostate (LAP) • Transurethral Incision of the Prostate (TUIP) • Condylomas • Urethral/ureteral strictures • Lesions of external genitalia • Bladder neck incisions (BNI) • Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors • Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi • Treatment of distal impacted fragments remaining in the ureters following lithotripsy.
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of renal calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
* Appendectomy * Angiodysplasia
* Polyps * Colorectal cancer
* Biopsy * Telangiectasias
* Gall Bladder calculi * Telangiectasias of the Osler-Weber-Renu disease
* Biliary/Bile duct calculi * Vascular Malformation
* Ulcers * Gastritis
* Gastric ulcers * Esophagitis
* Duodenal ulcers * Esophageal ulcers
* Non Bleeding Ulcers * Varices
* Pancreatitis * Colitis
* Haemorrhoids * Mallory-Weiss tear
* Cholecystectomy * Gastric Erosions
* Benign and Malignant Neoplasm
Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
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/K221306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221306
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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