Premier-CryOmega

FDA UDI

Class II (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name: Premier-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 that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • 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: 160-4008 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 that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • 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: 9034008 FDA UDI
Primary DI / UDI-DI: D6919034008 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cryogenic spray, cutaneous

Premier-CryOmega by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
CryoLab Aesthetics — CRYOCONCEPTS, LP · Class II

Cleared under the same submission

K102006 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: Premier Dental Products Company

Sources (1)

FDA UDI f7010b82-32f7-4f70-ade8-c9d4fedd77b1 37 fields · synced Jun 8, 2026