Duns Number:117030786
Device Description: Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applicat Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialtiesof general and plastic surgery, and dermatology.
Catalog Number
-
Brand Name
EpilMe System
Version/Model Number
300-1601
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
K213261
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
b55d3acf-cdad-409c-827d-fdc3691e5a12
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |