Manufacturer
Omni-Guide Holdings, Inc.LISA Laser Surgical Fibers
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K220189
- Device name
- LISA Laser Surgical 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
- 2022-01-24
- Decision date
- 2022-04-29
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1Laser Peripherals, LLC Family of Bare Laser Fibers
K220189 references 1 predicate/reference device
Cited as predicate
3InnoVoyce Laser Fiber
OmniGuide RFID Surgical Laser Fibers
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
3 submissions cite K220189 as a predicate
