Cry-Ac, Cry-Ac-3, Cry-Baby
by Brymill Cryogenic Systems EUDAMED510(k)
Active
510(k) K193619
Overview
The Cry-Ac, Cry-Ac-3, and Cry-Baby are cryosurgical units and accessories designed for controlled freezing of tissue. These devices employ cryogenic technology to deliver precise, localized cold therapy, commonly used in procedures such as skin lesion removal, wart treatment, and cosmetic applications like fat reduction or skin tightening.
These devices are intended for use in clinical settings by trained professionals and are supplied as reusable medical equipment. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). The Cry-Ac and Cry-Ac-3 models are authorized via FDA 510(k) clearance and are intended for general and plastic surgery applications. Sterility is not applicable as these are reusable instruments, and their use must adhere to standard infection control protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK193619 | Date25 Mar 2020 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brymill Cryogenic Systems
Questions
Are these devices single-use or reusable, and what does that mean for infection control during use?
The Cry-Ac®, Cry-Ac-3®, and Cry-Baby are reusable medical devices, meaning they are designed for repeated use after proper cleaning, disinfection, and sterilization between procedures. Since they are not sterile out-of-the-box, their use must strictly follow standard infection control protocols to ensure patient safety. This includes thorough cleaning, disinfection, and sterilization between applications, as outlined in the manufacturer’s instructions.
What clinical applications are these devices primarily intended for, and which specialties would benefit from them?
These cryosurgical units are designed for controlled freezing of tissue and are commonly used in general and plastic surgery procedures. They are particularly suited for applications like skin lesion removal, wart treatment, cosmetic fat reduction, and skin tightening. The devices are authorized for these uses under the FDA 510(k) clearance and the Medical Device Directive (MDD), making them suitable for clinicians in dermatology, cosmetic surgery, and related specialties.
How do I determine which model (Cry-Ac, Cry-Ac-3, or Cry-Baby) is right for my practice?
The Cry-Ac® and Cry-Ac-3® are both FDA 510(k)-cleared cryosurgical units intended for general and plastic surgery applications, with the primary distinction likely being in their specific cryogenic delivery systems or accessories (as referenced by their unique FEI numbers). The Cry-Baby appears to be a related model but lacks explicit FDA clearance details in the provided data. For precise model selection, consult the manufacturer’s documentation or contact Brymill Cryogenic Systems directly, as their intended use and technical specifications may vary slightly.
What regulatory pathway was followed for FDA clearance, and how does this affect my purchase or use?
The Cry-Ac® and Cry-Ac-3® devices were cleared via the FDA 510(k) pathway, specifically under Traditional Review by the Skin and Soft Tissue (SU) Advisory Committee. This means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA regulations for Class II devices. For purchasing or use, this clearance confirms their safety and effectiveness for cryosurgical applications as described, but you should always verify the latest regulatory status with the FDA’s database or the manufacturer.