Combination attachable delivery unit (YC-1800) - This combination delivery unit is need to - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: This combination delivery unit is need to comprise the combination system which enables yo 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 performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laserbeam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted.The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800.

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More Product Details

Catalog Number

-

Brand Name

Combination attachable delivery unit (YC-1800)

Version/Model Number

17148-0000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

b558542b-43a1-4f1a-96c8-5b99fdd6230f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDEK CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 73
3 A medical device with high risk that requires premarket approval 5