YAG laser combination delivery unit (YC-200)

GUDID 04987669101650

delivery unit is connected to the laser photocoagulator and YAG laser system to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) or photodisruption using a Nd:YAG laser beam (1064 nm, hereafter referred to as “YAG laser beam”) or SLT laser (532 nm, for YC-200 S plus only) while observing the patient’s eye with the slit lamp.

NIDEK CO.,LTD.

Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption Ophthalmic solid-state laser system, photodisruption
Primary Device ID04987669101650
NIH Device Record Keybef4481b-0681-477d-b9bd-0c0fb1c45367
Commercial Distribution StatusIn Commercial Distribution
Brand NameYAG laser combination delivery unit (YC-200)
Version Model Number17148-K020
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669101650 [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

Devices Manufactured by NIDEK CO.,LTD.

04987669200018 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200049 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200070 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200094 - Pachymetry probe2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200100 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200117 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
04987669200780 - IOL-Station2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
04987669100844 - IOL-Station2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica

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