HKS — Prism, Gonioscopic Class I
FDA product code HKS covers "Prism, Gonioscopic", a Class I medical device regulated under 21 CFR 886.1660. Submissions are reviewed by the Ophthalmic panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HKS
- Device Class
- Class I
- Regulation Number
- 886.1660
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140368 | sensor medical technology | FAMILY OF DISPOSABLE LENSES | April 29, 2014 |
| K935302 | ocular instruments | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | April 1, 1994 |
| K895846 | ocular instruments | TWO MIRROR GONIO LENS | December 18, 1989 |
| K890977 | ocular instruments | MCINTYRE SURGICAL GONIOLENS | May 23, 1989 |
| K862713 | ocular instruments | ABRAHAM IRIDECTOMY LENS (YAG LASER) | August 21, 1986 |
| K862692 | ocular instruments | KARICKHOFF DIAGNOSTIC/LASER LENS | August 21, 1986 |
| K862024 | ocular instruments | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | July 11, 1986 |
| K862512 | ocular instruments | RITCH TRABECULOPLASTY LASER LENS | July 11, 1986 |
| K861027 | keta | KETA HAND-HELD TONOMETER | May 6, 1986 |
| K830169 | jedmed instrument | DORC ADJUSTABLE IMAGE CONTACTS | February 7, 1983 |