Duns Number:038024868
Device Description: The CryoClear™ is a multi-use disposable device intended for the removal of target tissue The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots)• Skin Tags• Actinic Keratosis (Sun Spots)• Acne (Cysts & Scars)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous Hyperplasia
Catalog Number
801-2001
Brand Name
CryoClear
Version/Model Number
801-2001
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
K102006,K102006
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
8020b0c8-1736-4c80-a365-648501338df2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10850077006057
Quantity per Package
10
Contains DI Package
00850077006050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |