Product code HKS— Ophthalmic
ABRAHAM IRIDECTOMY LENS (YAG LASER)
- Classification name
- Prism, Gonioscopic
- Device class
- Class 1
- Regulation
- 21 CFR 886.1660
- Advisory panel
- Ophthalmic
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code HKS
FDA has cleared devices under product code HKS between 1983 and 2014, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2014
- 1994
- 1989
- 1986
- 1983
Top applicants under product code HKS
Recent clearances under product code HKS
- K140368 — FAMILY OF DISPOSABLE LENSES
- K935302 — OSHER SURGICAL GONIO/POSTERIOR POLE LENS
- K895846 — TWO MIRROR GONIO LENS
- K890977 — MCINTYRE SURGICAL GONIOLENS
- K862692 — KARICKHOFF DIAGNOSTIC/LASER LENS
- K862713 — ABRAHAM IRIDECTOMY LENS (YAG LASER)
- K862024 — SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
- K862512 — RITCH TRABECULOPLASTY LASER LENS
- K861027 — KETA HAND-HELD TONOMETER
- K830169 — DORC ADJUSTABLE IMAGE CONTACTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.