510(k) · Cleared
ClearedLitho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Dec 1, 2016 as substantially equivalent to K141101 (Quanta System Spa, 2014) and 1 other predicate after a 34-day review. Its family tree reaches back 7 generations to 1994. 12 later devices descend from it.
- Decided
- Dec 1, 2016
- Review
- 34 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). 12 later devices descend from it, 3 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 deviceK163009 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
- Descendant · 3 generations on · 6 of its ownK180922 Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018
- Descendant · 3 generations on · 5 of its ownK192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020
- Descendant · 4 generations on · 3 of its ownK201455 Litho 150, Cyber Ho 150Quanta System Spa · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170331Cyber HoQuanta System Spa · 2017 · cites it directly9descendants
- K172025Litho 60Quanta System Spa · 2017 · 2 generations on8descendants
- K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa · 2018 · 3 generations on6descendants
- K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa · 2020 · 3 generations on5descendants
- K201455Litho 150, Cyber Ho 150Quanta System Spa · 2020 · 4 generations on3descendants
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) | K163009 | Litho | Quanta System Spa | 2016 | — |
| +1 | K170331 | Cyber Ho | Quanta System Spa | 2017 | — |
| +2 | K172025 | Litho 60 | Quanta System Spa | 2017 | — |
| +3 | K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa | 2018 | — |
| +3 | K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | 2020 | — |
| +4 | K201455 | Litho 150, Cyber Ho 150 | Quanta System Spa | 2020 | — |
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 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K141101 | LITHOSummary page 6…October 26™ 2016 Litho Class | Laser surgical instrument for use in general and plastic surgery and in dermatology. 21 CFR 878.4810 GEX Device modifications Litho (K141101 ) — Quanta System SPA Lumenis Pulse 120h (K140388) — Lumenis LTD There are no mandatory performance standards for this device.… | 2014 |
| * | K140388 | Lumenis Pulse 120HSummary page 6…instrument for use in general and plastic surgery and in dermatology. 21 CFR 878.4810 GEX Device modifications Litho (K141101 ) — Quanta System SPA Lumenis Pulse 120h (K140388) — Lumenis LTD There are no mandatory performance standards for this device. 5-1 Description of the modificatio… | 2014 |
What descends from it? (12)
See all 123 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 22 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K170331 (Quanta System Spa, 2017) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K141101.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Litho laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision. excision. resection. ablation. vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology. Urinary Lithotripsy. Gastroenterology. Arthroscopy, Dlst.euomy Gynaecology. ENT and General Surgery. Urology Open and endoscopic surgery (incision, excision…
Read the full statement (469 words)
The Litho laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision. excision. resection. ablation. vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology. Urinary Lithotripsy. Gastroenterology. Arthroscopy, Dlst.euomy Gynaecology. ENT and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection. ablation. vaporization. coagulation and hacmostasis) including:
* Urethral Strictures
* Bladder Neck Incisions (BNI)
* Ablation and resection of Bladder Tumors. Uretheral Tumors and Ureteral » Tumors,
» Ablation of Benign Prostatic Hypertrophy (BHP).
* Transurethral incision of the prostate (TUIP)
+ Holmium Laser Resection of the Prostrate (HoLRP)
* Holmium Laser Enucleation of the Prostate (HoLEP)
* Holmium laser Ablation of the Prostate (HoLLAP)
* Condylomas
* Lesions of external genitalia
Lithotripsy and Percutancous 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 haemostasis) including:
+ Appendectomy
* Polyps
* Biopsy
» Gall Bladder calculi
* Biliary/Bile duct calculi
* Ulcers
* Gastric ulcers
« Duodenal ulcers
» Non Bleeding Ulcers
« Pancreatitas
« Haemorrhoids
* Cholecystectomy
» Benign and Malignant Neoplasm
« 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/Orthopaedic 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
» Chondreplasty in the Knee
* Debridement of inflamed synovial tissue
+ Chondromalacia Ablation
» Chondromalacia and tears
* Plica Removal
* Meniscectomy
* Loose Body Debridement
« Lateral retinecular release
Ablation of soft. cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
» Percutaneous Laser Disc Decompression/Discectomy of the Ld-5 and L5-SI lumbar discs. including Foraminoplasty
Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision. excision. resection. ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision. excision, resection, ablation. vaporization. coagulation and haecmostasis of soft tissue and cartilage) including:
+ Endonasal/sinus Surgery
» Partial turbinectomy
* Polypectomy
+» Dacryocystorhinostomy
* Frontal Sinusotomy
* Ethmoidectomy
+ Maxillary antrostomy
* Functional endoscopic sinus surgery
General Surgery
Open. laparoscopic and endoscopic surgery (incision. excision. resection. ablation, vaporization, coagulation and haemostasis) including:
* Appendectomy
+ Skin incision
* Excision of external and internal lesions
» Complete of 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/K163009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163009: Litho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163009
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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