HRN
10 FDA 510(k) clearances · Product code
111 daysmedian time to decision
328 days90th percentile
10clearances measured
FDA profile
- Official device name
- Unit, Cryophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MIRA Adapter (K200911) | Phakos | 2020-06-02 |
| Frigitronics adapter (K180195) | Phakos | 2018-03-16 |
| PHAKOS Disposable Retinal Cryo Probe (K162756) | Phakos | 2017-05-03 |
| D.O.R.C. Disposable Cryo Probe (K160591) | Dutch Ophthalmic Research Center International BV | 2017-01-23 |
| CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (K131787) | Keeler, Ltd. | 2013-12-23 |
| CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (K112093) | Keeler Instruments, Inc. | 2011-12-08 |
| CRYOMATIC (K062412) | Keeler Instruments, Inc. | 2006-11-06 |
| D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (K012821) | Dutch Ophthalmic USA, Inc. | 2001-10-22 |
| KEELER CRYO MASTER & PROBES (K992954) | Keeler Instruments, Inc. | 1999-12-21 |
| CLIRANS TE08 HOLLOW FIBER DIALYZER (K823768) | Terumo Medical Corp. | 1983-01-08 |
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Every clearance here is in the API, with alerts when new ones post.