Duns Number:690635461
Device Description: The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO.
Catalog Number
-
Brand Name
BIO delivery unit (Heine OMEGA)
Version/Model Number
17379-0000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
e61f8433-b2d5-4273-9a4d-710b085c3e2a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 01, 2017
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 |