Manufacturer
Dornier Medtech America, Inc.Dornier Medilas H Solvo 35 Laser
Country / Region:United States (US)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
- K180350
- Device name
- Dornier Medilas H Solvo 35 Laser
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-02-08
- Decision date
- 2018-03-07
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Solvo 35W is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties: ° Arthroscopy ° Urology ° Lithotripsy ° Pulmonology ° Gastroenterology ° Gynecology ° ENT ° General Surgery
Intended Use
The Solvo 35W is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery.
Device Description
The Dornier Medilas H Solvo 35 Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400 µm (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Solvo can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coagulation and vaporization. The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The Dornier Medilas H Solvo 35 has the same technological characteristics as the Dornier H30 Solvo Laser to which it is a modification. The primary difference in technical performance characteristics is the available maximum power and frequency and the option to use pre-set laser settings. The Dornier Medilas H Solvo 35 has a maximum power of 35W while the Dornier H30 Solvo Laser has a maximum power of 30W.
Summary parsed at:2026-06-01 05:57:04 UTC
Predicate devices
2—
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Not ingested
Litho
K180350 references 2 predicate/reference devices
Cited as predicate
1Dornier Thulio
1 submission cite K180350 as a predicate
