Duns Number:690635461
Device Description: delivery unit is connected to the laser photocoagulator and YAG laser system to comprise t delivery unit is connected to the laser photocoagulator and YAG laser system to comprise the photocoagulation system and to treat affected areas using a slit lamp.The photocoagulation system enables photocoagulation using a green laser beam (532 nm) or photodisruption using a Nd:YAG laser beam (1064 nm, hereafter referred to as “YAG laser beam”) or SLT laser (532 nm, for YC-200 S plus only) while observing the patient’s eye with the slit lamp.
Catalog Number
-
Brand Name
YAG laser combination delivery unit (YC-200)
Version/Model Number
17148-K020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
bef4481b-0681-477d-b9bd-0c0fb1c45367
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |