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Cyber Ho

Quanta System Spa

Country / region:Italy (IT)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Quanta System Spa
Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

1
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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

K170331 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K170331 as a predicate