Ophthalmic YAG Laser System

GUDID 04987669101452

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.

NIDEK CO.,LTD.

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Primary Device ID04987669101452
NIH Device Record Keyf163362f-1b11-4d31-bfed-eb037c9089ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameOphthalmic YAG Laser System
Version Model NumberYC-200
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669101452 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

On-Brand Devices [Ophthalmic YAG Laser System]

04987669100073The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) p
04987669101452The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main
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