FDA product code HQA: Unit, Cryotherapy, Ophthalmic
HQA is the FDA product code for unit, cryotherapy, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HQA, from 2 different applicants. The average 510(k) review took 70 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cryotherapy, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.4170 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HQA clearance
Top HQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 2 | 1985-12-30 |
| Keller Instruments, Inc. | 2 | 1984-08-15 |
Most recent HQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854422 | Keeler Instruments, Inc. | SERIES 25 SLIMLINE CRYO PROBES | 1985-12-30 | 56 |
| K854411 | Keeler Instruments, Inc. | KEELER-COMPACT CRYO SYSTEM | 1985-12-30 | 59 |
| K841294 | Keller Instruments, Inc. | ACU220 CRYO UNIT | 1984-08-15 | 139 |
| K823835 | Keller Instruments, Inc. | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | 1983-01-17 | 27 |
Recalls for HQA devices
openFDA lists no recalls for product code HQA.
Frequently asked questions
What is FDA product code HQA?
HQA is the FDA product code for unit, cryotherapy, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel.
What device class is HQA?
Class II, regulation 21 CFR 886.4170. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQA?
Across 4 cleared submissions the average was 70 days from receipt to decision (median 58).
Which companies have the most HQA clearances?
Keeler Instruments, Inc. (2); Keller Instruments, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HQA
- Run a recall and safety report across every HQA manufacturer
- Watch product code HQA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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