# K180922: Empower H100, Cyber Ho 100, Litho 100

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: May 8, 2018 after 29 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 37 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172025: Litho 60, Quanta System Spa (2017) Summary page 6.

## Most influential descendants
- K192600: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 (2020), 5 descendants of its own
- K201455: Litho 150, Cyber Ho 150 (2020), 3 descendants of its own
- K253951: Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (2026), 0 descendants of its own
- K252771: Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) (2025), 0 descendants of its own
- K242251: Litho 60; Litho 100; Litho 150 (2024), 0 descendants of its own

## Indications for use
The Multicavity Holmium 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, Discectomy, Gynaecology, ENT and General Surgery. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: • Urethral Strictures • Bladder Neck Incisions (BNI) • Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, • Ablation of Benign Prostatic Hypertrophy (BPH), • 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 (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 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 L4-5 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 haemostasis 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

Source page: https://510kreport.com/device/K180922
Methodology: https://510kreport.com/methodology