510(k) · Cleared
ClearedLumenis Pulse 120H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Mar 14, 2014 as substantially equivalent to K011703 (Lumenis, 2001) after a 28-day review. Its family tree reaches back 6 generations to 1994. 34 later devices descend from it.
- Decided
- Mar 14, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K936109 (1994). 30 ancestors in all, the oldest K853620 (1986). 34 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 1 generation backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- This deviceK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
- Descendant · cites it directly · 17 of its ownK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 12 of its ownK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
- Descendant · cites it directly · 12 of its ownK163009 LithoQuanta System Spa · 2016
- Descendant · cites it directly · 9 of its ownK170331 Cyber HoQuanta System Spa · 2017
- Descendant · 2 generations on · 8 of its ownK172025 Litho 60Quanta System Spa · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd. · 2017 · cites it directly17descendants
- K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America · 2019 · 2 generations on12descendants
- K163009LithoQuanta System Spa · 2016 · cites it directly12descendants
- K170331Cyber HoQuanta System Spa · 2017 · cites it directly9descendants
- K172025Litho 60Quanta System Spa · 2017 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −1 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| 0 (this device) | K140388 | Lumenis Pulse 120H | Lumenis, Ltd. | 2014 | — |
| +1 | 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 | K163009 | Litho | Quanta System Spa | 2016 | — |
| +1 | K170331 | Cyber Ho | Quanta System Spa | 2017 | — |
| +2 | K172025 | Litho 60 | Quanta System Spa | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Summary page 2…stic Surgery Predicate Device: Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) Surgical Lasers And Delivery Devices And Accessories [Lumenis], Cleared under K01 1703 Intended Use/ Indications for Use: The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) Surgical Lasers and… | 2001 |
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K170121 (Lumenis, Ltd., 2017) has gone furthest, with 17 descendants of its own.
- 18 other devices also cite its predicate K011703.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) Surgical Lasers and Delivery Devices and Accessories - Lumenis Pulse 120H is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.NT. surgery; gynecological surgery; pulmonary surgery; gastroenterology…
Read the full statement (583 words)
The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) Surgical Lasers and Delivery Devices and Accessories - Lumenis Pulse 120H is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.NT. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The Lumenis Pulse 120H System and the currently marketed VersaPulse PowerSuite Holmium Surgical Lasers with Delivery Devices and Accessories are indicated for use in the performance of specific surgical applications as follows:
Urology
* Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
- Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: bladder; superficial and invasive bladder, urethral and ureteral tumors; condylomas; lesions of external genitalia; ureteral and penile hemangioma; ureteral strictures; bladder neck obstructions
* Urinary Lithotripsy including: endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Arthroscopy
* Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: meniscectomy; plica removal; ligament and tendon release; contouring and sculpting of articular surfaces; debridement of inflamed synovial tissue (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release; capsulectomy in the knee; chondroplasty in the knee; chondromalacia ablation.
* Discectomy including: percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.
General Surgery
» Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy; lysis of adhesions; appendectomy; biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; skin incision; tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors and 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; biopsy.
ENT Surgery
» Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: partial turbinectomy; ethmoidectomy; polypectomy; maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS).
Gynecological Surgery
» Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).
Gasteroenterology Surgery
« Open and endoscopic gasteroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: gall bladder calculi; biliary/bile duct calculi; benign and malignant neoplasm; polyps; colitis; ulcers; angiodysplasia; hemorrhoids; varices; esophagitis; esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions; colorectal cancer; gastritis; bleeding tumors; pancreatitis; vascular malformations; telangiectasis; telangiectasias of the Osler-Weber-Renu disease.
Pulmonary Surgery
* Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue.
Dermatology and plastic surgery
- Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including: scars; tattoo removal; vascular lesions; port wine stains; hemangioma; telangiectasia of the face and leg; rosacea; corns; papillomas; basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts; periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization.
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/K140388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140388: Lumenis Pulse 120H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140388
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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