FDA.reportPublic FDA data

BIO delivery unit (Heine OMEGA)

Primary DI
04987669100288
Brand
BIO delivery unit (Heine OMEGA)
Company
NIDEK CO.,LTD.
Model
17112-0000
Device description
This unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC- 1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. delivery unit (HEINE OMEGA 500). The comprised photocoagulation system makes it possible to switch between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O.
Published
2017-02-03
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669100288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669100288049876691002884987669100288

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31
04987669101049DIGITAL MEDICAL SCOPEDS-10G2017-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16