510(k) · Cleared
ClearedIpgtfl-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ipg Medical Corporation · GEX Powered Laser Surgical Instrument
Cleared on Sep 19, 2025 as substantially equivalent to K232568 (Ipg Medical Corporation, 2024) after a 162-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Sep 19, 2025
- Review
- 162 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K936109 (1994). 37 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations between
- 3 generations backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
- 2 generations backK211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…Gyrus Acmi, Inc. · 2021 · Recalled
- 1 generation backK232568 IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and…Ipg Medical Corporation · 2024 · Recalled
- This deviceK251100 Ipgtfl-02Ipg Medical Corporation · 2025
Show all 11 generations
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 9 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 8 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 7 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 6 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 5 generations backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
- 4 generations backK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
- 3 generations backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
- 2 generations backK211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium…Gyrus Acmi, Inc. · 2021 · Recalled
- 1 generation backK232568 IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and…Ipg Medical Corporation · 2024 · Recalled
- This deviceK251100 Ipgtfl-02Ipg Medical Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −10 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −8 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −7 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −6 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −5 | K140388 | Lumenis Pulse 120H | Lumenis, Ltd. | 2014 | — |
| −4 | K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | Lumenis, Ltd. | 2017 | 1 |
| −3 | 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 |
| −1 | K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Ipg Medical Corporation | 2024 | 1 |
| 0 (this device) | K251100 | Ipgtfl-02 | Ipg Medical Corporation | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSummary page 6…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK232568 IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, IGEX… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 37 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 IPGTFL-02 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 Prostate (LRP) • Laser Enucleation of the Prostate (LEP) • Laser Ablation of the Prostate (LAP)…
Read the full statement (292 words)
The IPGTFL-02 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 Prostate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral 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 with integrated detection of calculi and mucosal tissue by StoneSense module that reduces exposure of mucosal tissue to laser energy and reduces resulting damage to mucosal tissue
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy:
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate 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 hemostasis) 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
• Hemorrhoids
• Mallory-Weiss tear
• Cholecystectomy
• Gastric Erosions
• Benign and Malignant Neoplasm
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251100: Ipgtfl-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251100
Report an extraction error
Are you the manufacturer?
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