Attachable delivery unit (SL-1800) - This delivery unit is connected to the NIDEK - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: This delivery unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 ( This delivery unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. The integrated delivery unit which incorporates the SL-1800 comprises the photocoagulation system in connection with the GYC-1000 main body. The attachable delivery unit is mainly the photocoagulation unit and the protective filter unit. They are attached to your slit lamp (NIDEK SL-1800) to comprise the integrated delivery unit. The comprisedintegrated delivery is connected to the GYC-1000 to comprise the photocoagulation system. This photocoagulation system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation of the affected area with the slit lamp.

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More Product Details

Catalog Number

-

Brand Name

Attachable delivery unit (SL-1800)

Version/Model Number

17402-0000

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

6f879421-aff0-483f-95a3-fbc4a632fbf5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 01, 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