Manufacturer
Wontech Co., Ltd.Air Gap Fiber
Country / Region:Korea, Republic of (KR)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
- K232106
- Device name
- Air Gap Fiber
- Company
- Wontech Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-07-14
- Decision date
- 2024-01-08
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOtherOtherOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.
Intended Use
The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.
Device Description
The WONTECH Air Gap Fibers are available in 3 sizes. These are 272, 365 and 550 microns and designated as hard clad silica/silica material. These sizes refer to the core diameters of the silica. All fibers are Low OH (hydroxide), especially adapted to delivering wavelengths of laser that are highly absorbed by water. However, for those wavelengths in which water absorption is not a limiting factor, Low OH fiber optic cables may be used as well. The fiber assemblies are configured with standardized SMA-905 connectors, which are the most commonly found connectors in use today. These Air Gap fibers are packaged in sterile, single use, peel away pouches for direct use in operating theaters. The Air Gap fibers are indicated for soft and hard tissue contact and prepared with a polished, flat distal end. The length of the Air Gap fibers is standardized at 3 meters. These Air Gap Fibers may be used with laser outputs from 1-120 watts. The Air Gap Fibers are intended for use in laser surgical procedures including open, laparoscopic or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable.
Summary parsed at:2026-06-01 05:26:30 UTC
Predicate devices
1Laser Peripherals, LLC Family of Bare Laser Fibers
K232106 references 1 predicate/reference device
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2Veincare
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2 submissions cite K232106 as a predicate
