510(k) · Cleared
ClearedMultiPulse HoPLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GEX Powered Laser Surgical Instrument
Cleared on Mar 31, 2017 as substantially equivalent to K131987 (Asclepion Laser Technologies GmbH, 2014) and 1 other predicate after a 331-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Mar 31, 2017
- Review
- 331 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K936109 (1994). 34 ancestors in all, the oldest K853620 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 3 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 2 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 1 generation backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
- This deviceK161257 MultiPulse HoPLUSAsclepion Laser Technologies GmbH · 2017
- Descendant · cites it directly · 0 of its ownK253633 Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −3 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −1 | K140388 | Lumenis Pulse 120H | Lumenis, Ltd. | 2014 | — |
| 0 (this device) | K161257 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | 2017 | — |
| +1 | K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026 | — |
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 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K131987 | Multipulse HoplusSummary page 6…GEX 21 CFR 878.4810 Equivalent Devices: MultiPulse HoPLUS K131987 Asclepion Laser Technologies Lumenis Pulse 120 K140388 Lumenis D… | 2014 |
| * | K140388 | Lumenis Pulse 120HSummary page 6…lent Devices: MultiPulse HoPLUS K131987 Asclepion Laser Technologies Lumenis Pulse 120 K140388 Lumenis Device Description: The MultiPulse HoPLUS Laser system and its fiber optic delivery… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | 2026 | 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?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K253633 (Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MULTIPULSE HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.…
Read the full statement (550 words)
The MULTIPULSE HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Typical Applications:
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
* Urethral Strictures
* Bladder Neck Incisions (BNI)
* Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors
* Ablation of Benign Prostatic Hypertrophy (BHP)
* Transurethral incision of the prostate (TUIP)
* Holmium Laser Resection of the Prostate (HoLRP)
* Holmium Laser Enucleation of the Prostate (HoLEP)
* Holmium laser Ablation of the Prostate (HoLAP)
* Condylomas
* Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
* Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
* Endoscopic fragmentation of kidney 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
* Polyps
* Biopsy
* Gall Bladder calculi
* Biliary/Bile duct calculi
* Ulcers
* Gastric ulcers
* Duodenal ulcers
* Non Bleeding Ulcers
* Pancreatitis
* Hemorrhoids
* Cholecystectomy
* Benign and Malignant Neoplasma
* Angiodysplasia
* Colorectal cancer
* Telangiectasias
* Telangiectasias of the Osler-Weber-Renu disease
* Vascular Malformation
* Gastritis
* Esophagitis
* Esophageal ulcers
* Varices
* Colitis
* Mallory-Weiss tear
* Gastric Erosions
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
* Ligament and tendon Release
* Contouring and sculpting of articular surfaces
* Capsulectomy in the Knee
* Chondreoplasty in the Knee
* Debridement of inflamed synovial tissue
* Chondromalacia Ablation
* Chondromalacia and tears
* Plica Removal
* Meniscectomy
* Loose Body Debridement
* Lateral retineacular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
* Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Forminoplasty
* Percutaneous Cervical Disc Decompression/Discectomy
* Percutaneous Thoracic Disc Decompression/Discectomy
Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue)
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including:
* Endonasal/sinus Surgery
* Partial turbinectomy
* Polypectomy
* Dacryocystorhinostomy
* Frontal Sinustomy
* Ethmoidectomy
* Maxillary antrostomy
* Functional endoscopic sinus surgery
Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:
* Basal Cell Carcinomas
* Lesions of skin and subcutaneous tissue
* Skin tags
* Plantar warts
* Lesions of skin and subcutaneous tissue
* Port Wine Stains
* Papillomas
General Surgery
Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
* Appendectomy
* Skin incision
* Excision of external lesions
* Complete or partial resection of internal organs, tumors and lesions
* Biopsy
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/K161257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161257: MultiPulse HoPLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161257
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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