FDA.reportPublic FDA data

Ophthalmic YAG Laser System

Primary DI
04987669101452
Brand
Ophthalmic YAG Laser System
Company
NIDEK CO.,LTD.
Model
YC-200
Device description
The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy.
Published
2021-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669101452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669101452049876691014524987669101452

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photodisruptionA mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.

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
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04562123289602SLIT LAMP SL-D4 (Type:LED)TOPCON CORPORATIONHJO2026-09-28
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQF2025-06-24
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
06945087565018EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2022-11-02
06945087500057EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2022-11-02
06945087520000RodenstockSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087525005RodenstockSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087525012RodenstockSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087590003TomeySHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087590010TomeySHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087590027TomeySHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-17
06945087540015EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-10
06945087540022EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-10
06945087545010EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-10
06945087545027EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HJO2021-05-10
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