Manufacturer
Dornier Medtech America, Inc.Medilas H Laser Fibers
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
- K161771
- Device name
- Medilas H Laser Fibers
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-06-28
- Decision date
- 2016-07-28
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ('Laser'). This laser is intended 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 Laser is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General SurgeryIntended Use
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ('Laser'). This laser is intended 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 Laser 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 RFID Laser Fiber has the same technological characteristics and principles of operation as the predicate device.
Summary parsed at:2026-06-01 06:06:42 UTC
Predicate devices
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Not ingested
Medilas H RFID Laser Fibers
K161771 references 2 predicate/reference devices
Cited as predicate
1Dornier Thulio
1 submission cite K161771 as a predicate
