Unit, Cryophthalmic, Ac-Powered
The AC-powered cryophthalmic unit is an ophthalmic surgical device that uses freezing temperatures to treat conditions of the eye, such as retinal detachment, cataract extraction, and glaucoma. It is regulated as an FDA Class 2 device under 21 CFR 886.4170, meaning it poses moderate risk and requires 510(k) premarket notification demonstrating substantial equivalence before marketing. Product code HRN falls under the Ophthalmic medical specialty. This device is eligible for third party review under the FDA's Accredited Persons Program.
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Basic Information
- Product Code
- HRN
- Device Class
- FDA class 2
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200911 | MIRA Adapter | Jun 02, 2020 | Substantially Equivalent | Phakos |
| K180195 | Frigitronics adapter | Mar 16, 2018 | Substantially Equivalent | Phakos |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | May 03, 2017 | Substantially Equivalent | Phakos |
| K160591 | D.O.R.C. Disposable Cryo Probe | Jan 23, 2017 | Substantially Equivalent | Dutch Ophthalmic Research Center International BV |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Dec 23, 2013 | Substantially Equivalent | Keeler, Ltd. |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | Dec 08, 2011 | Substantially Equivalent | Keeler Instruments, Inc. |
| K062412 | CRYOMATIC | Nov 06, 2006 | Substantially Equivalent | Keeler Instruments, Inc. |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Oct 22, 2001 | Substantially Equivalent | Dutch Ophthalmic USA, Inc. |
| K992954 | KEELER CRYO MASTER & PROBES | Dec 21, 1999 | Substantially Equivalent | Keeler Instruments, Inc. |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Jan 08, 1983 | Substantially Equivalent | Terumo Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.