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CryoClear
CRYOCONCEPTS, LP · Model 801-2001 · UDI-DI 00850077006050
GEH
Prescription
1
510(k) clearances
3,274
Adverse events (57 deaths)
107
Recalls
112
Facilities
Description
The CryoClear™ is a multi-use disposable device intended for the removal 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. • Lentigo (Age Spots) • Skin Tags • Actinic Keratosis (Sun Spots) • Acne (Cysts & Scars) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia
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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Get your free API keyRead the docsData 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.