Duns Number:657731175
Device Description: The TruScan 577 is a laser system included laser console with pattern scanning laser deliv The TruScan 577 is a laser system included laser console with pattern scanning laser delivery unit and ophthalmic powered table. There are three boxs individually.
Catalog Number
-
Brand Name
LightMed TruScan 577
Version/Model Number
ML0015
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
K142172
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
1a069be2-6a57-4508-86de-1dc71052ca9a
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |