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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2025-07-21
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16