Manufacturer
Quanta System SpaMH01
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K152220
- Device name
- MH01
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-08-07
- Decision date
- 2015-09-03
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The MH01 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 hemostasis 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 MH01 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 hemostasis 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.
Device Description
The modified device MH01 is a tower version of the already cleared device Litho DK30 (K141403). It differs from Litho DK30 in the housing of components (tower frame instead of desktop) and a modified graphic user interface. Both devices are Pulsed Holmium:YAG lasers with a maximum output power of 30 W @ 2.1 µm, sharing the same architecture and laser source. The modifications include a new mechanical structure housing the internal components and a reviewed GUI.
Summary parsed at:2026-06-01 06:11:33 UTC
Predicate devices
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K152220 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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