Is this your brand? Sign in to claim ownership.

OMNIGUIDE, INC.

Last updated May 31, 2026

What OMNIGUIDE, INC. makes

Omniguide, Inc. makes various medical devices, including urogenital and ophthalmic surgical laser system beam guides, dermatological carbon dioxide laser systems, microbial medical gas filters, and electrosurgical handpieces. Their products also include general and multiple surgical diode/carbon dioxide laser systems. Examples of their devices are the Velocity High Performance Fiber, BeamPath OTO Handpiece Set, and NEURO Handpiece Tray.

The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) and FDA UDI registries. Omniguide, Inc. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of products does Omniguide, Inc. manufacture?

Omniguide, Inc. makes medical devices such as urogenital and ophthalmic surgical laser system beam guides, dermatological carbon dioxide laser systems, and electrosurgical handpieces, which are examples of their product range.

Where is Omniguide, Inc. based?

Omniguide, Inc. is based in the US, as indicated by its country of origin.

Which registries list Omniguide, Inc.'s devices?

The company's devices are listed in the FDA 510(k) and FDA UDI registries, which track medical devices.

How are Omniguide, Inc.'s devices classified?

Omniguide, Inc.'s devices are regulated as Class II devices, indicating their level of risk and required oversight.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: omni-guide.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-666-4484
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 030124221

Catalogue (76)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
GYN-LAP Handpiece, 33cm, Bent	GYN-LAP-33B	FDA UDI	Class II	Active
OMNIGUIDE BeamPath OTO-U Fiber	OTO-U	FDA UDI	Class II	Active
Elevate™ENT Handpiece 22cm 45°/15° -S	321012	FDA UDI	Class II	Active
Handpiece Tray for AccuBeam Otology	OTO-TRAY	FDA UDI	Class II	Active
OmniGuide® OmniFlex Instrument Set	341004	FDA UDI	Class II	Active
Elevate™ENT Handpiece 7cm 25°-S	321003	FDA UDI	Class II	Active
Elevate™ENT Handpiece 22cm 45°/30°	321009	FDA UDI	Class II	Active
GYN Handpiece Mark III, 6 cm Bent	GYN-HP-6B	FDA UDI	Class II	Active
Elevate™ENT Handpiece 22cm 45°/0° -S	321008	FDA UDI	Class II	Active
BeamPath GYN-LAP Handpiece Set	GYN-HS-LAP-1	FDA UDI	Class II	Active
GYN-Laparoscopic Handpiece, 29 cm, Straight	GYN-HP-29	FDA UDI	Class II	Active
OmniGuide® LapFlex Tray	341002	FDA UDI	Class II	Active
Omniguide Zero Flow Zf-T 150 Waveguide Fiber	K063141	FDA 510(k)	Class II	Active
Omniguide Beampath Co2 Mark Iii Waveguide Fiber With Low Profile/Low Loss Tip	K093451	FDA 510(k)	Class II	Active
OmniGuide BeamPath OTO-U Fiber	K203241	FDA 510(k)	Class II	Active
Beacon Advanced CO2 Laser System	K180993	FDA 510(k)	Class II	Active
TRIO Handpiece	K183199	FDA 510(k)	Class II	Active
Flexguide Ultra Beampath Robotic Fiber Conduit	K140378	FDA 510(k)	Class II	Active
Omniguide Beampath Fels 25a Co2 Laser System	K093251	FDA 510(k)	Class II	Active
Highland Beam Delivery System, Model 3-099-002-00-00	K061909	FDA 510(k)	Class II	Active
Mark Iii Waveguide Fiber With Low Profile Tip	K073313	FDA 510(k)	Class II	Active
Omniguide Zero Flow Zf-T Waveguide Fiber	K070071	FDA 510(k)	Class II	Active
Omniguide Beampath Laser Beam Delivery System	K062423	FDA 510(k)	Class II	Active
Omniguide Sterile Waveguide Adapter System	K073409	FDA 510(k)	Class II	Active
Omniguide Beam Path Co2 Mark Iii Waveguide Fiber	K070157	FDA 510(k)	Class II	Active
Omniguide Beampath Fiber Optic Handpiece System And Sterilization Tray	K081939	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.