InnoVoyce Laser Fiber

Innovoyce

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K220793
Device name
InnoVoyce Laser Fiber
Company
Innovoyce
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-03-18
Decision date
2022-05-25
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. 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

InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. 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

The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.

Summary parsed at:2026-06-01 05:39:55 UTC

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