HPS
11 FDA 510(k) clearances · Product code
86 daysmedian time to decision
192 days90th percentile
11clearances measured
FDA profile
- Official device name
- Unit, Cryophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2000: 2 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CryoTreQ (K202038) | VitreQ BV | 2020-12-30 |
| OPHTHALMIC CRYO UNIT (K940373) | Dutch Ophthalmic USA, Inc. | 1994-07-18 |
| OPHTHALMIC TRICHIASIS PROBE (K923629) | Mira, Inc. | 1992-10-19 |
| SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (K903303) | Spembly Medical , Ltd. | 1990-10-11 |
| KEELER ACU 22XT OPHTHALMIC CRYO UNIT (K874555) | Keeler Instruments, Inc. | 1988-01-29 |
| KEELER CTU CRYO SYSTEM (K873388) | Keeler Instruments, Inc. | 1987-11-13 |
| UNITED SURGICAL CORP. CRYOPTIC PLUS (K870195) | United Surgical Corp. | 1987-02-20 |
| GALLIE CRYONUCLEATOR (K833747) | Mono Research Laboratories | 1984-05-09 |
| KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (K801418) | Keeler Optical Products , Ltd. | 1980-07-21 |
| BEAVER CATARACT CYROXTRACTOR (K781338) | Edward Weck, Inc. | 1979-02-12 |
| MODEL 556-01 CRYOEXTRACTOR (K790102) | Intermedics, Inc. | 1979-02-12 |
Track HPS automatically
Every clearance here is in the API, with alerts when new ones post.