Manufacturer
Quanta System SpaCyber Ho
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K170331
- Device name
- Cyber Ho
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-02-02
- Decision date
- 2017-03-03
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and in Lithotripsy of stones. It is indicated in medical specialties including, but not limited to: Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.
Intended Use
The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and in Lithotripsy of stones. It is indicated in medical specialties including, but not limited to: Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.
Summary parsed at:2026-06-01 05:59:40 UTC
Predicate devices
2—
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Not ingested
Litho
K170331 references 2 predicate/reference devices
Cited as predicate
1Litho 60
1 submission cite K170331 as a predicate