Unit, Cryotherapy, Ophthalmic
An Ophthalmic Cryotherapy Unit is a surgical device that uses controlled extreme cold applied through a probe to treat ophthalmic conditions including retinal detachment (cryopexy), glaucoma, and intraocular tumors by creating precisely localized tissue freezing effects. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQA 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
- HQA
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854422 | SERIES 25 SLIMLINE CRYO PROBES | Dec 30, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K854411 | KEELER-COMPACT CRYO SYSTEM | Dec 30, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K841294 | ACU220 CRYO UNIT | Aug 15, 1984 | Substantially Equivalent | Keller Instruments, Inc. |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | Jan 17, 1983 | Substantially Equivalent | Keller Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.