Duns Number:547954649
Device Description: For eye examination and aid in the diagnosis.Contraindications: none.Target groups of pati For eye examination and aid in the diagnosis.Contraindications: none.Target groups of patients: adults, children.Intended users: optometrists in hospital ophthalmology and optical shops.The people who use this product are ophthalmologists in hospitals or clinics, and optometrists in optical shops. To operate this product, they should have relevant knowledge of eye examinations and have the relevant skills to operate the product.
Catalog Number
-
Brand Name
YEASN
Version/Model Number
YF-100
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161764
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
0b6b094f-33b3-4222-a62e-774e95200c67
Public Version Date
August 04, 2022
Public Version Number
1
DI Record Publish Date
July 27, 2022
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |