Scan Attachable delivery unit (SL130) - The delivery unit is connected to the YELLOW - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system (SOLIC *1) that ensures low laser power density on the anterior segment is incorporated. The ZEISS SL130 type is available.A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). The ZEISS SL130 type is available: *1 Safety Optics with Low Impact on Cornea

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More Product Details

Catalog Number

-

Brand Name

Scan Attachable delivery unit (SL130)

Version/Model Number

GEA01

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

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

c1bccbad-b50b-4689-880b-d78dcab92ff5

Public Version Date

May 21, 2018

Public Version Number

1

DI Record Publish Date

April 20, 2018

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