Identity
- Trade Name
- CryoLab Medical FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, 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 molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis. FDA UDI
- Model / Reference
- 200-1000 FDA UDI
- Description
- The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, 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 molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis. FDA UDI
Identifiers
- Catalog Number
- 200-1000 FDA UDI
- Primary DI / UDI-DI
- 00850077006067 FDA UDI
- 510(k) Number
- K190407 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryogenic spray, cutaneous FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cryogenic spray, cutaneous
CryoLab Medical by Cryoconcepts, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190407 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cryoconcepts, Lp
Sources (1)
- FDA UDI bbc58d36-cb27-4c7d-8a54-091e3a65514f 37 fields · synced May 30, 2026