HPS — Unit, Cryophthalmic Class II
FDA product code HPS covers "Unit, Cryophthalmic", a Class II medical device regulated under 21 CFR 886.4170. Submissions are reviewed by the Ophthalmic panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HPS
- Device Class
- Class II
- Regulation Number
- 886.4170
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202038 | vitreq | CryoTreQ | December 30, 2020 |
| K940373 | dutch ophthalmic usa | OPHTHALMIC CRYO UNIT | July 18, 1994 |
| K923629 | mira | OPHTHALMIC TRICHIASIS PROBE | October 19, 1992 |
| K903303 | spembly medical | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | October 11, 1990 |
| K874555 | keeler instruments | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | January 29, 1988 |
| K873388 | keeler instruments | KEELER CTU CRYO SYSTEM | November 13, 1987 |
| K870195 | united surgical | UNITED SURGICAL CORP. CRYOPTIC PLUS | February 20, 1987 |
| K833747 | mono research laboratories | GALLIE CRYONUCLEATOR | May 9, 1984 |
| K801418 | keeler optical products | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | July 21, 1980 |
| K781338 | edward weck | BEAVER CATARACT CYROXTRACTOR | February 12, 1979 |
| K790102 | intermedics | MODEL 556-01 CRYOEXTRACTOR | February 12, 1979 |