D.O.R.C. CryoStar Cryosurgical System
by Dutch Ophthalmic USA, Inc. 510(k)
Active
510(k) K012821
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012821 | Date22 Oct 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4170
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The D.O.R.C. CryoStar Cryosurgical System is an AC-powered ophthalmic cryosurgical unit classified as a cryophthalmic device. It is designed for controlled freezing of ocular tissues, primarily used in procedures such as cryopexy for retinal detachment, glaucoma management, and other posterior or anterior segment surgeries.
This system is intended for use in sterile surgical settings and is supplied as a reusable medical device. It operates under FDA 510(k) clearance (K012821) and is regulated under the classification of Class II devices. Components are engineered for ophthalmic procedures, adhering to strict medical standards for safety and efficacy in cryosurgical applications.
Other devices from Dutch Ophthalmic USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of ophthalmic procedures is the D.O.R.C. CryoStar Cryosurgical System primarily used for?
The D.O.R.C. CryoStar Cryosurgical System is primarily designed for controlled freezing of ocular tissues in procedures like cryopexy for retinal detachment repair, as well as glaucoma management and other posterior or anterior segment surgeries. Its specialized cryophthalmic function ensures precise tissue freezing during these delicate ophthalmic interventions.
Is the D.O.R.C. CryoStar Cryosurgical System reusable or single-use, and how should it be maintained?
The D.O.R.C. CryoStar Cryosurgical System is a reusable medical device, meaning it is intended for repeated use in sterile surgical settings. Since it is not single-use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality between procedures, adhering to standard ophthalmic device care guidelines.
What power source does the D.O.R.C. CryoStar Cryosurgical System require, and is it compatible with standard surgical environments?
The D.O.R.C. CryoStar Cryosurgical System is AC-powered, meaning it requires access to a standard electrical outlet. This design ensures compatibility with typical surgical environments where electrical power is readily available, making it a practical choice for cryosurgical procedures in ophthalmology.
How is the regulatory status of this device determined, and what classification does it hold?
The D.O.R.C. CryoStar Cryosurgical System holds a Traditional 510(k) clearance (K012821) from the FDA, classified as a Class II device. Its regulatory pathway was determined through a review by the Ophthalmic (OP) Advisory Committee, confirming it is substantially equivalent to a legally marketed predicate device under the HRN product code for cryophthalmic, AC-powered units.
What safety and sterility considerations should be taken into account when using this system in surgery?
The D.O.R.C. CryoStar is explicitly designed for sterile surgical settings, meaning all components must be properly sterilized before use to prevent contamination. Since it is reusable, adherence to strict sterilization protocols (e.g., autoclaving or chemical sterilization) is critical. The system’s cryophthalmic function also requires careful handling to avoid unintended tissue damage, ensuring precise control during procedures like cryopexy or glaucoma management.