Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical 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.
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical 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.
High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm – 2100nm. Fiber having a Numerical Aperture (NA) between 0.22 – 0.48. 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. Connectors include SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors. Fiber construction includes Core – Fused Silica, Clad – Fused Silica or Fluoropolymer Hard Cladding, Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate, Jacket – Nylon, Polyimide, or Teflon. Fibers are compatible with any cleared laser system with an appropriate connection system.
Summary parsed at:2026-06-01 05:39:41 UTC
Laser Peripherals, LLC Family of Bare Laser Fibers
K220189 references 1 predicate/reference device
