AccessGUDID - DEVICE: Ophthalmic YAG Laser System (04987669101452)

GUDID

Device Identifier (DI) Information

Brand Name: Ophthalmic YAG Laser System
Version or Model: YC-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy.

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):	No
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?
16947	Ophthalmic solid-state laser system, photodisruption	A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, Ophthalmic
HJO	Biomicroscope, Slit-Lamp, Ac-Powered

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: f163362f-1b11-4d31-bfed-eb037c9089ea
Public Version Date: October 04, 2021
Public Version Number: 1
DI Record Publish Date: September 24, 2021