Product code HQA
- Device name
- Unit, Cryotherapy, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4170
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854411 | KEELER-COMPACT CRYO SYSTEM | Keeler Instruments, Inc. | 1985-12-30 |
| K854422 | SERIES 25 SLIMLINE CRYO PROBES | Keeler Instruments, Inc. | 1985-12-30 |
| K841294 | ACU220 CRYO UNIT | Keller Instruments, Inc. | 1984-08-15 |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | Keller Instruments, Inc. | 1983-01-17 |
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