Product code HRN
- Device name
- Unit, Cryophthalmic, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4170
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-10-22 |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | 1999-12-21 |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1983-01-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055272707503 | ADAPTOR FOR F SIZE CO2 CYLINDER | KEELER LIMITED | 2025-03-26 |
| 05055272707527 | ADAPTOR FOR F SIZE N2O CYLINDER | KEELER LIMITED | 2025-03-26 |
| 05055272721424 | DORC CRYOSTAR ADAPTOR | KEELER LIMITED | 2025-03-26 |
| 05055272721431 | ERBE ERBOKRYO ADAPTOR | KEELER LIMITED | 2025-03-26 |
| 05055272720113 | Single Use Retinal Cryo Probe (Box of 10 Probes) | KEELER LIMITED | 2020-11-09 |
| B564MVCY1000 | PHAKOS | PHAKOS | 2018-10-22 |
| B564MVAD97NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD99NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD98NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD96NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD95NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD94NG0 | PHAKOS | PHAKOS | 2018-10-03 |
| B564MVAD930 | PHAKOS | PHAKOS | 2018-10-03 |
| 08717872021416 | Cryo Probe: Extended Retinal, 2.5mm | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2017-07-12 |
| 10816340021066 | NeoDevices, Inc. | NEODEVICES INC | 2016-09-24 |
| 05055272711852 | 3mm Glaucoma Probe | KEELER LIMITED | 2016-08-16 |
| 05055272711845 | 1.5mm Curved Cataract Probe | KEELER LIMITED | 2016-08-16 |
| 05055272711838 | 0.89mm Intra Vitreal Probe | KEELER LIMITED | 2016-08-16 |
| 05055272711821 | 2.5mm Mid-Reach Retinal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272711814 | 2.5mm Extended Retinal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272711760 | Cryomatic MkII Standard Retinal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272711753 | Cryomatic MkII Console | KEELER LIMITED | 2016-08-16 |
| 05055272707701 | 4x10mm Collins Trichiasis Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707695 | 3mm Glaucoma Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707688 | 1.5mm Curved Cataract Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707671 | 0.89mm Intra-Vitreal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707664 | 2.5mm Mid-Reach Retinal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707657 | 2.5mm Extended Retinal Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707640 | Cryomatic 2.5mm Std Ret Pencil | KEELER LIMITED | 2016-08-16 |
| 05055272707633 | Cryomatic Console | KEELER LIMITED | 2016-08-08 |