Identity
- Trade Name
- CryOmega FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions of lesions that can be treated: • Actinic Keratosis • Genital Lesions • Lentigo • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plana • Verruca Plantaris • Verruca VulgarisAngiomas • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue. FDA UDI
- Model / Reference
- 160-2002 FDA UDI
- Description
- The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions of lesions that can be treated: • Actinic Keratosis • Genital Lesions • Lentigo • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plana • Verruca Plantaris • Verruca VulgarisAngiomas • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue. FDA UDI
Identifiers
- Catalog Number
- 160-2002 FDA UDI
- Primary DI / UDI-DI
- 00850077006210 FDA UDI
- 510(k) Number
- K102006 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 16 Gram FDA UDI
Category: Cryogenic spray, cutaneous
CryOmega by Cryoconcepts, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryogenic spray, cutaneous.
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- Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
Cleared under the same submission
K102006 also covers:
- FREEZPOINT™ — BOVIE MEDICAL CORPORATION
- FREEZPOINT™ — BOVIE MEDICAL CORPORATION
- CryOmega — CRYOCONCEPTS, LP
- CryoClear — CRYOCONCEPTS, LP
- CryoClear — CRYOCONCEPTS, LP
- Premier CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
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 c7642614-4102-4bbf-beec-e279752ab7ae 38 fields · synced Jun 1, 2026