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CryOmega

CRYOCONCEPTS, LP · Model 160-2001 · UDI-DI 00850077006005

GEH Prescription

510(k) clearances

3,274

Adverse events (57 deaths)

107

Recalls

112

Facilities

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.

Recalls

Date	Firm	Reason
2026-08-24	Limitless Cryo Spa LLC	Lack of 510(k) clearance.
2026-06-26	Erbe USA Inc	A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the
2026-02-12	Erbe USA Inc	Probes may rupture/burst during activation
2026-02-12	Erbe USA Inc	Probes may rupture/burst during activation
2026-02-12	Erbe USA Inc	Probes may rupture/burst during activation
2025-08-18	Boston Scientific Corporation	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-08-18	Boston Scientific Corporation	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-03-24	Boston Scientific Corporation	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings
2025-03-24	Boston Scientific Corporation	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings
2025-03-24	Boston Scientific Corporation	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.