PHAKOS Disposable Retinal Cryo Probe
FDA 510(k) K162756 · Phakos
510(k) numberK162756
Submission
- Device name
- PHAKOS Disposable Retinal Cryo Probe
- Applicant
- Phakos
Montreuil, FR - Received
- September 30, 2016
- Decision date
- May 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRN – Unit, Cryophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
Other 510(k)s with product code HRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200911 | MIRA AdapterHRN · Traditional | Phakos | 06/02/2020SE |
| K180195 | Frigitronics adapterHRN · Traditional | Phakos | 03/16/2018SE |
| K160591 | D.O.R.C. Disposable Cryo ProbeHRN · Traditional | Dutch Ophthalmic Research Center International BV | 01/23/2017SE |
| K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesHRN · Special | Keeler, Ltd. | 12/23/2013SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | Keeler Instruments, Inc. | 12/08/2011SE |
| K062412 | CryomaticHRN · Traditional | Keeler Instruments, Inc. | 11/06/2006SE |
| K012821 | D.O.R.C. Cryostar Cryosurgical SystemHRN · Traditional | Dutch Ophthalmic USA, Inc. | 10/22/2001SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | Keeler Instruments, Inc. | 12/21/1999SE |
| K823768 | Clirans TE08 Hollow Fiber DialyzerHRN · Traditional | Terumo Medical Corp. | 01/08/1983SE |
More from Terumo Medical Corp.
Questions and answers
When was PHAKOS Disposable Retinal Cryo Probe cleared by the FDA?
PHAKOS Disposable Retinal Cryo Probe (K162756) received a 510(k) decision of Substantially Equivalent on May 3, 2017, 215 days after the submission was received.
What is the product code of K162756?
The FDA product code is HRN – Unit, Cryophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4170.