Manufacturer
Omniguide, Inc.OmniGuide BeamPath OTO-U Fiber
Country / Region:United States (US)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
- K203241
- Device name
- OmniGuide BeamPath OTO-U Fiber
- Company
- Omniguide, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-11-03
- Decision date
- 2021-01-14
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngology, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
Intended Use
The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngology, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
Device Description
The OmniGuide Beam Path OTO-U Fiber is a single use laser surgical instrument provided sterile for use in transmitting laser energy at 10.6 µm from a CO2 Laser System to a surgical site through an endoscope, flexible or rigid or using an accessory handpiece. It is connected to the laser system utilizing a standard ST II stainless steel fitting which is used by many laser manufacturers. The fiber assembly is 1 to 2 meters long and transmits at the CO2 laser emission of 10.6 µm. The fiber can be used in single pulse mode, repeat pulse mode and CW mode. Power output is limited to 10 Watts.
Summary parsed at:2026-06-01 05:42:16 UTC