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Sign in to claim this brandCRYOCONCEPTS, LP
United States·US-MF-000009822
Last updated May 30, 2026
What CRYOCONCEPTS, LP makes
The company produces cryosurgical systems and associated consumables, including general cryosurgical devices that use cryogen gases and mechanical methods for tissue freezing. It also manufactures cryogenic spray systems designed for cutaneous applications, such as precise skin treatments.
These devices are authorised under Class II and Class IIa regulatory classifications, with listings in the EUDAMED database, FDA’s 510(k) premarket notification process, and the FDA’s Unique Device Identifier (UDI) system. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CryoConcepts, LP manufacture?
CryoConcepts, LP specializes in cryosurgical systems and related consumables. Their devices include general cryosurgical systems that use cryogen gases and mechanical methods to freeze tissue, as well as cryogenic spray systems specifically designed for cutaneous (skin) treatments. These systems are engineered for precise tissue ablation or controlled freezing in medical procedures.
Where is CryoConcepts, LP based?
CryoConcepts, LP is headquartered in the United States. The company’s location influences its regulatory compliance, particularly with U.S. FDA requirements and participation in global registries like EUDAMED.
Which regulatory registries list CryoConcepts, LP’s devices?
CryoConcepts, LP’s devices are listed in multiple regulatory databases, including EUDAMED (the European Union’s medical device registry), the FDA’s 510(k) premarket notification database (for U.S. clearance pathways), and the FDA’s Unique Device Identifier (UDI) system, which standardizes device tracking and identification globally.
How are CryoConcepts, LP’s devices classified under medical device regulations?
CryoConcepts, LP’s devices fall under Class II and Class IIa regulatory classifications. These classifications are determined by factors like the device’s intended use, potential risks, and the level of regulatory oversight required. Class II devices typically involve moderate risk and require special controls beyond general controls, while Class IIa devices are a subset with slightly lower risk but still require premarket notification (e.g., FDA 510(k)) or other regulatory pathways.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1100, Conroy Place, Easton, United States
- Website
- www.cryoconcepts.com
- —
- —
- [email protected]
- Phone
- 16109366168
- PRRC Contact
- Walter Peters
- EUDAMED SRN
- US-MF-000009822
- FDA FEI Number
- —
- DUNS Number
- 038024868
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Histofreezer | 1001-0294 | FDA UDI | Class II | Active |
| CryOmega | 160-2002 | FDA UDI | Class II | Active |
| Histofreezer FLEX | 200-3050 | FDA UDI | Class II | Active |
| CryoClear | 161-2001 | FDA UDI | Class II | Active |
| Histofreezer | 1001-0295 | FDA UDI | Class II | Active |
| Histofreezer | 1001-0336 | FDA UDI | Class II | Active |
| Histofreezer FLEX | 200-6080 | FDA UDI | Class II | Active |
| Histofreezer | 1001-0375 | FDA UDI | Class II | Active |
| Histofreezer FLEX | 200-4051 | FDA UDI | Class II | Active |
| CryOmega | 800-2001 | FDA UDI | Class II | Active |
| Histofreezer | 1001-0293 | FDA UDI | Class II | Active |
| CryoClear | 801-2001 | FDA UDI | Class II | Active |
| CryoLab Aesthetics | 700-1000 | FDA UDI | Class II | Active |
| Histofreezer FLEX | 200-5052 | FDA UDI | Class II | Active |
| CryoLab Medical | 200-1000 | FDA UDI | Class II | Active |
| CryoClear Multi-Use Disposable Cryosurgical Device - 16g International | 1500-1001 | EUDAMED | Class IIa | Active |
| Scholl Freeze Away Skin Tag Remover | 1500-1044 | EUDAMED | Class IIa | Active |
| Skin Clinic Nitro Clear Wart Remover | K242932 | FDA 510(k) | Class II | Active |
| CryoLab | K190407 | FDA 510(k) | Class II | Active |
| CryoTouch | K183601 | FDA 510(k) | Class II | Active |
| Freeze’n Clear Skin Clinic Warts & Tags | K211099 | FDA 510(k) | Class II | Active |
| Skin Clinic Freeze Point for Warts and Skin Tags | K251493 | FDA 510(k) | Class II | Active |
| Freeze Point & Private Label Versions | K242625 | FDA 510(k) | Class II | Active |
| Histofreezer Professional - H602 | 1001-0408 | EUDAMED | Class IIa | Active |
| CryOmega | 160-2001 | EUDAMEDFDA UDI | Class IIa | Active |
| Scholl Freeze Away Skin Tag Remover | 1500-1042 | EUDAMED | Class IIa | Active |
| Histofreezer Professional - H-30M | 1001-0341 | EUDAMED | Class IIa | Active |
| CryoTag Skin Tag Remover | 1001-0542 | EUDAMED | Class IIa | Active |
| Histofreezer Professional - H505 | 1001-0409 | EUDAMED | Class IIa | Active |
| Scholl Freeze Verruca and Wart Remover | 1001-0177 | EUDAMED | Class IIa | Active |
| CryOmega | 160-2004 | EUDAMEDFDA 510(k) | Class IIa | Active |
| Scholl Freeze Verruca and Wart Remover | 1001-0376 | EUDAMED | Class IIa | Active |
| Scholl Pharma Expert Treatment Verruca Freeze Verruca | 1001-0174 | EUDAMED | Class IIa | Active |
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