FDA Product Code
FDA Product Code HPS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4170
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202038 | CryoTreQ | VitreQ BV | 2020-12-30 | Traditional | PDF ↗ |
| K940373 | OPHTHALMIC CRYO UNIT | Dutch Ophthalmic USA, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Mira, Inc. | 1992-10-19 | Traditional | PDF ↗ |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Spembly Medical , Ltd. | 1990-10-11 | Traditional | PDF ↗ |
| K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | Keeler Instruments, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K873388 | KEELER CTU CRYO SYSTEM | Keeler Instruments, Inc. | 1987-11-13 | Traditional | PDF ↗ |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | United Surgical Corp. | 1987-02-20 | Traditional | PDF ↗ |
| K833747 | GALLIE CRYONUCLEATOR | Mono Research Laboratories | 1984-05-09 | Traditional | PDF ↗ |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Keeler Optical Products , Ltd. | 1980-07-21 | Traditional | PDF ↗ |
| K790102 | MODEL 556-01 CRYOEXTRACTOR | Intermedics, Inc. | 1979-02-12 | Traditional | PDF ↗ |
| K781338 | BEAVER CATARACT CYROXTRACTOR | Edward Weck, Inc. | 1979-02-12 | Traditional | PDF ↗ |
Product code HPS · Class II · Ophthalmic. Data: openFDA.