FDA.reportPublic FDA data

Beacon Advanced Energy CO2 Laser System

Primary DI
00852306007715
Brand
Beacon Advanced Energy CO2 Laser System
Company
OMNIGUIDE, INC.
Model
60 Watt
Catalog number
420060-AA
Device description
A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber
Published
2018-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180993000Beacon Advanced CO2 Laser SystemOmniguide, Inc.2018-06-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852306007715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852306007715008523060077158523060077150852306007715

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-666-4484customerservice@omni-guide.com

Regulatory Flags#

DUNS number
030124221
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852306007753OMNIGUIDE BeamPath OTO-U FiberOTO-UOTO-U2025-04-08
00852306007708TRIO Handpiece13230002019-06-06
00894338002672BeamPath NEURO-L FiberNEURO-LNEURO-L2016-09-22
00894338002818BeamPath ROBOTIC fiberROBOTICROBOTIC2016-09-22
00894338002825Elevate™ ENT Elite Fiber3220013220012016-09-22
00894338002849Omniguide Select Fiber3220033220032016-09-20
00894338002856Velocity™ High Performance Fiber3320053320052016-09-22
10894338002693Gas Filter UnitACC-GFU-100ACC-GFU-1002016-09-22
00894338002726FELS Laser SystemFELS-25AFELS-25A2016-09-22
00894338002009Elevate ENT Handpiece 5cm 0° -S3210173210172016-09-21
00894338002016Flexguide Ultra HandpieceFLEXGUIDE-ULTRAFLEXGUIDE-ULTRA2016-09-22
00894338002023Elevate™ENT Handpiece 7cm 0°-S3210023210022016-09-22
00894338002030Elevate™ENT Handpiece 7cm 25°-S3210033210032016-09-22
00894338002047BeamPath OTO-S fiberOTO-SOTO-S2016-09-22
00894338002054BeamPath OTO-M fiberOTO-MOTO-M2016-09-22
00894338002351Handpiece Tray for AccuBeam OtologyOTO-TRAYOTO-TRAY2016-09-22
00894338002740Elevate™ENT Handpiece 15cm 25°-S3210043210042016-09-22
00894338002771Elevate™ENT Handpiece 17cm 45°/0° -S3210053210052016-09-22
00894338002863Lapflex, Laparoscopic Articulating Handpiece- 33cm3410013410012016-09-22
00894338002870Elevate™ENT Handpiece 17cm 45°/30°3210063210062016-09-22

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