Manufacturer
Omni-Guide Holdings, Inc.OmniGuide RFID Surgical Laser Fibers
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
- K230819
- Device name
- OmniGuide RFID Surgical Laser Fibers
- Company
- Omni-Guide Holdings, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-03-24
- Decision date
- 2023-04-21
- Submission type
- Special
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
Intended Use
OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
Device Description
High OH or Low OH silica material with low attenuation of light wavelengths between 532nm – 2100nm. Fiber having a Numerical Aperture (NA) between 0.22 – 0.48. Core - Fused Silica; Clad - Fused Silica or Fluoropolymer Hard Cladding; Buffer - Fluoropolymer Hard Cladding or Silicone Acrylate Jacket - Nylon, Polyimide, or Teflon. Multiple configurations of distal tips offered to provide the most suitable performance for the application. Core diameters are offered in a range of sizes suitable to user needs. Fibers are compatible with any cleared laser system with an appropriate connection system. Sterilization method is EtO.
Summary parsed at:2026-06-01 05:32:50 UTC
Predicate devices
1LISA Laser Surgical Fibers
K230819 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230819 as a predicate
