AccessGUDID - DEVICE: Yellow Laser Photocoagulator (04987669101117)

GUDID

Device Identifier (DI) Information

Brand Name: Yellow Laser Photocoagulator
Version or Model: YLC-500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator consisting of a main laser device, a control box, and a power supply. With various types of laser delivery units, it comprises a photocoagulation system. The YLC-500 uses a 577 nm optically pumped semiconductor laser (yellow laser beam) as the treatment beam source. The pumped yellow laser beam (treatment beam) and the aiming beam (635 nm, red laser beam) are fed coaxially into the fiber optic cable. The output terminal of the fiber optic cable is connected to a delivery unit. The laser beam is formed into the desired spot size by the optical system, then the laser beam is emitted to the target area. The delivery units are equipped with a protective filter that protects the physician’s eyes from exposure to the treatment beam reflected from the patient’s eye or contact lens.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36150	General/multiple surgical frequency-doubled solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63d63cc8-6074-451a-8ed2-937a056b2b9f
Public Version Date: May 21, 2018
Public Version Number: 1
DI Record Publish Date: April 20, 2018