FDA.reportPublic FDA data

Combination attachable delivery unit (YC-1800)

Primary DI
04987669100318
Brand
Combination attachable delivery unit (YC-1800)
Company
NIDEK CO.,LTD.
Model
17148-0000
Device description
This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while perfo
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04987669100318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669100318049876691003184987669100318

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204610Open-field Refraction SystemPHANTOM2026-01-08
04987669204917Open-field Refraction SystemPHANTOM Conrtol Box2026-01-08
04987669200018 A-scan probe14130-00012023-07-10
04987669200049 Pachymetry probe (45° fixed type)14130-00062023-07-10
04987669200070A-scan probe14610-00062023-07-10
04987669200094Pachymetry probe14610-01072023-07-10
04987669200100Pachymetry probe (45° fixed type)14610-01082023-07-10
04987669200117 A-scan probe14611-00062023-07-10
04987669200780IOL-Station1.212023-07-10
04987669100844IOL-Station1.202023-06-12
04987669101544MICROPERIMETERMP-3 type S2023-06-12
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669101711REFRACTORRT-6002023-06-12
04987669200636Image filing software NAVIS-EX1.122023-06-12
04987669200773AL-Scan Viewer for NAVIS-EX1.32023-06-12
04987669203477OPTICAL BIOMETERAL-Scan39NNNN2023-06-12
04987669203651OPTICAL BIOMETERAL-Scan32NNNN2023-06-12
04987669607350CEM Viewer for NAVIS-EX1.12023-06-12
04987669101575CHART PROJECTORCP-92021-10-01
04987669101452Ophthalmic YAG Laser SystemYC-2002021-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
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02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
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