Duns Number:436887608
Device Description: The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in the handpi The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD).Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
Catalog Number
M081AN1
Brand Name
Thermaeye Plus
Version/Model Number
M081AN1
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
K082040
Product Code
ONF
Product Code Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Public Device Record Key
6aa4d02d-48e7-4396-a8f0-69b3b21611cb
Public Version Date
October 27, 2021
Public Version Number
1
DI Record Publish Date
October 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |