Duns Number:038024868
Device Description: The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray of Carbon Dioxide gas to treat topical cutaneous lesions. The intended use for the CryoLab® Aesthetics, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include skin tags, actinic keratosis, and seborrheic keratosis.
Catalog Number
700-1000
Brand Name
CryoLab Aesthetics
Version/Model Number
700-1000
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
K190407
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
10908e7a-48f9-4b79-a95f-09d15394473a
Public Version Date
July 11, 2019
Public Version Number
1
DI Record Publish Date
July 03, 2019
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. | 12 |