FDA Product Code
FDA Product Code HRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4170
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200911 | MIRA Adapter | Phakos | 2020-06-02 | Traditional | PDF ↗ |
| K180195 | Frigitronics adapter | Phakos | 2018-03-16 | Traditional | PDF ↗ |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017-05-03 | Traditional | PDF ↗ |
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | 2017-01-23 | Traditional | PDF ↗ |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Keeler, Ltd. | 2013-12-23 | Special | PDF ↗ |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | Keeler Instruments, Inc. | 2011-12-08 | Special | PDF ↗ |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | 2006-11-06 | Traditional | PDF ↗ |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1983-01-08 | Traditional | PDF ↗ |
Product code HRN · Class II · Ophthalmic. Data: openFDA.