Unit, Cryophthalmic
A Cryophthalmic Unit is an ophthalmic surgical device that uses cryogenic cooling to create a localized cold probe tip, used in procedures such as cataract extraction (cryoextraction), retinal detachment repair (cryopexy), and treatment of tumors or lid lesions by controlled freezing of ocular tissue. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPS and is regulated under 21 CFR 886.4170, within the Ophthalmic medical specialty. It is eligible for third-party review.
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Basic Information
- Product Code
- HPS
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202038 | CryoTreQ | Dec 30, 2020 | Substantially Equivalent | VitreQ BV |
| K940373 | OPHTHALMIC CRYO UNIT | Jul 18, 1994 | Substantially Equivalent | Dutch Ophthalmic USA, Inc. |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Oct 19, 1992 | Substantially Equivalent | Mira, Inc. |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Oct 11, 1990 | Substantially Equivalent | Spembly Medical , Ltd. |
| K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | Jan 29, 1988 | Substantially Equivalent | Keeler Instruments, Inc. |
| K873388 | KEELER CTU CRYO SYSTEM | Nov 13, 1987 | Substantially Equivalent | Keeler Instruments, Inc. |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | Feb 20, 1987 | Substantially Equivalent | United Surgical Corp. |
| K833747 | GALLIE CRYONUCLEATOR | May 09, 1984 | Substantially Equivalent | Mono Research Laboratories |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Jul 21, 1980 | Substantially Equivalent | Keeler Optical Products , Ltd. |
| K790102 | MODEL 556-01 CRYOEXTRACTOR | Feb 12, 1979 | Substantially Equivalent | Intermedics, Inc. |
| K781338 | BEAVER CATARACT CYROXTRACTOR | Feb 12, 1979 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.