HRN — Unit, Cryophthalmic, Ac-Powered Class II
FDA product code HRN covers "Unit, Cryophthalmic, Ac-Powered", a Class II medical device regulated under 21 CFR 886.4170. Submissions are reviewed by the Ophthalmic panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HRN
- Device Class
- Class II
- Regulation Number
- 886.4170
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200911 | phakos | MIRA Adapter | June 2, 2020 |
| K180195 | phakos | Frigitronics adapter | March 16, 2018 |
| K162756 | phakos | PHAKOS Disposable Retinal Cryo Probe | May 3, 2017 |
| K160591 | dutch ophthalmic research center international | D.O.R.C. Disposable Cryo Probe | January 23, 2017 |
| K131787 | keeler | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | December 23, 2013 |
| K112093 | keeler instruments | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | December 8, 2011 |
| K062412 | keeler instruments | CRYOMATIC | November 6, 2006 |
| K012821 | dutch ophthalmic usa | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | October 22, 2001 |
| K992954 | keeler instruments | KEELER CRYO MASTER & PROBES | December 21, 1999 |
| K823768 | terumo medical | CLIRANS TE08 HOLLOW FIBER DIALYZER | January 8, 1983 |