510(k) · Cleared
Recalled · 2007Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis · GEX Powered Laser Surgical Instrument
Cleared on Aug 29, 2001 as substantially equivalent to K990947 (Lumenis, Inc., 1999) and 3 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1994. 342 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 29, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K936109 (1994). 29 ancestors in all, the oldest K853620 (1986). 342 later devices descend from it, 19 citing it directly.
- Root · 5 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 4 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 3 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 2 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 1 generation backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- This deviceK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001
- Descendant · cites it directly · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
- Descendant · cites it directly · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- Descendant · 2 generations on · 122 of its ownK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- Descendant · 3 generations on · 121 of its ownK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- Descendant · cites it directly · 119 of its ownK014290 Entec Plasma WandsArthrocare Corp. · 2002
Showing 5 of 342 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 342 · See all- K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · cites it directly136descendants
- K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · cites it directly136descendants
- K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010 · 2 generations on122descendants
- K103626Cutera Genesisplus Laser SystemCutera, Inc. · 2011 · 3 generations on121descendants
- K014290Entec Plasma WandsArthrocare Corp. · 2002 · cites it directly119descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −4 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −2 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −1 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| 0 (this device) | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | — |
| +1 | K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers | Patholase, Inc. | 2009 | — |
| +1 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| +2 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
| +3 | K103626 | Cutera Genesisplus Laser System | Cutera, Inc. | 2011 | — |
| +1 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
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 |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 18 | 0 |
| 2013 | 21 | 0 |
| 2014 | 15 | 0 |
| 2015 | 15 | 0 |
| 2016 | 26 | 0 |
| 2017 | 16 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 32 | 0 |
| 2026 | 25 | 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? (4)
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 |
|---|---|---|---|
| * | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Summary page 1…Lasers and Delivery Devices with Accessories Laser Powered Surgical Instrument (and Accessories) Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K990947); 1500-A) (K002308) « Dornier Medilas H/2 Laser System (K984591) « Convergent Odyssey 30 Laser System (K951910). IV. Product D… | 1999 |
| * | K002308 | Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model…Summary page 1…Devices with Accessories Laser Powered Surgical Instrument (and Accessories) Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K990947); 1500-A) (K002308) « Dornier Medilas H/2 Laser System (K984591) « Convergent Odyssey 30 Laser System (K951910). IV. Product Description Trimedyn… | 2000 |
| * | K984591 | Dornier Medilas H/2Summary page 1…cal Instrument (and Accessories) Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K990947); 1500-A) (K002308) « Dornier Medilas H/2 Laser System (K984591) « Convergent Odyssey 30 Laser System (K951910). IV. Product Description Trimedyne Holmium Laser Systems (model 1210, model 101… | 1999 |
| * | K951910 | Odyssey HO:Yag Surgical Laser Systems & AccessoriesSummary page 1…G) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K990947); 1500-A) (K002308) « Dornier Medilas H/2 Laser System (K984591) « Convergent Odyssey 30 Laser System (K951910). IV. Product Description Trimedyne Holmium Laser Systems (model 1210, model 1010-VHP, and model The Modified Lumenis VersalPu… | 1995 |
What descends from it? (342)
See all 34219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers | 2009 | 136 |
| K083215 | Incisive Family of Inpulse ND:Yag Lasers | 2009 | 136 |
| K014290 | Entec Plasma Wands | 2002 | 119 |
| K140388 | Lumenis Pulse 120H | 2014 | 34 |
| K120926 | Endobeam Holmium Laser Fibers | 2012 | 24 |
| K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 | 23 |
| K082928 | Straight Fire Holmium Laser Fiber | 2008 | 6 |
| K131473 | (Quanta System) Surgical Laser Fibers | 2013 | 5 |
| K100078 | Modified Straight Fire Laser Fiber | 2010 | 5 |
| K061455 | Dornier Medilas H 20 Laser | 2006 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2007 | Not classified | Z-0585-2008 | Labeling mix-ups | Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner… |
| Aug 29, 2006 | Not classified | Z-0028-2007 | Other | Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K083616 (Patholase, Inc., 2009) has gone furthest, with 136 descendants of its own.
- 4 other devices also cite its predicate K990947.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: • Ho:YAG- urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery…
Read the full statement (1,221 words)
The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:
• Ho:YAG- urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.
• Nd:YAG- urology; general surgery; gastroenterology; thoracic & pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.
The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows:
Ho:YAG - 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.
Nd:YAG - Urology
Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including removal of superficial bladder tumors; removal of invasive bladder carcinoma; removal of benign or malignant lesions of the external genitalia, including condylomas; treatment of urethral strictures; treatment of vascularities of the bladder wall; prostatectomy.
Ho:YAG — 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.
Nd:YAG - Orthopaedic Surgery
Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Knee—capsulectomy in the knee; chondroplasty in the knee; plica removal in the knee; lateral ligament release in the knee; meniscectomy in the knee; synovectomy in the knee; osteoarthritic lesion removal in the knee. Shoulder—coracoacromial release in the shoulder; debridement of scar tissue in the shoulder; adhesive capsule release in the shoulder; labral tear repair in the shoulder; synovectomy in the shoulder.
Discectomy: limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with unilateral leg pain greater than back pain; paresthetic discomfort in a specific dermatomal distribution; positive straight leg raising test and/or positive bowstring sign; possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration; no improvement after at least 6 weeks of conservative therapy; positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.
Ho:YAG - 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.
Nd:YAG - General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including cholecystectomy; mastectomy; hepatectomy; pancreatectomy; splenectomy; hemorrhoidectomy; thyroidectomy; parathyroidectomy; herniorrhaphy; tonsillectomy; appendectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma; pelvic adhesiolysis; removal of lesions; removal of polyps; removal of tumors; tumor biopsy; debridement of decubitus ulcers.
Ho:YAG - E.N.T. 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).
Nd:YAG - E.N.T. Surgery
Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues; tonsillectomy; adenoidectomy.
Ho:YAG - Gynecological Surgery
Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).
Nd:YAG - Gynecological Surgery
Gynecological surgery limited to treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization; intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation; intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips; soft tissue excisional procedures such as excisional conization of the cervix.
Ho:YAG - 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; telangiectasias; telangiectasias of the Osler-Weber-Renu disease.
Nd:YAG - Gastroenterology Surgery
Gastroenterology surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia; gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions; gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.
Ho:YAG - Pulmonary Surgery
Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue).
Nd:YAG - Thoracic and Pulmonary Surgery
Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of laryngeal lesions; airway obstructions including carcinoma; polyps and granulomas; palliation of obstructing carcinomas of the tracheobronchial tree.
Ho:YAG — Dermatology and Plastic Surgery
Incision, excision, resection, ablation, coagualation, 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.
Nd:YAG - Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including lesions of skin and subcutaneous tissue; telangiectasia; port wine lesions; spider veins; hemangiomas; plantar warts; periungual and subungual warts; removal of tattoos; debridement of decubitus ulcer; treatment of keloids.
Nd:YAG - Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including matrixectomy; plantar warts; neuromas; periungual and subungual warts; radical nail excision.
Nd:YAG - Neurosurgery
Neurosurgery limited to hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.
Nd:YAG - Ophthalmology
Ophthalmology limited to post-vitrectomy photocoagulation.
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/K011703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011703
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026