Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
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
LISA Laser Surgical Fibers
K230819 references 1 predicate/reference device
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