510(k) K012821
- Device
- D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- Applicant
- DUTCH OPHTHALMIC USA, INC.
- 510(k) number
- K012821
- Product code
- HRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-22
- Date received
- 2001-08-23
- Regulation
- 886.4170
- Classification name
- Unit, Cryophthalmic, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK W FURLONG
- Address
- One Little River Rd. P.O. Box 968 Kingston NH US 03848 03848
FDA Registration Numbers#
- 3006142778
- 1000391004
- 2521877
- 9611516
Source Documents#
Other 510(k) Records For Product Code HRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200911 | MIRA Adapter | Phakos | 2020-06-02 |
| K180195 | Frigitronics adapter | Phakos | 2018-03-16 |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017-05-03 |
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | 2017-01-23 |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Keeler, Ltd. | 2013-12-23 |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | Keeler Instruments, Inc. | 2011-12-08 |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | 2006-11-06 |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | 1999-12-21 |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1983-01-08 |
Legacy Summary#
summary
FDA Review#
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