Product code HKW— Ophthalmic
OPTHALMIC BAR PRISM
- Classification name
- Prism, Bar, Ophthalmic
- Device class
- Class 1
- Regulation
- 21 CFR 886.1650
- Advisory panel
- Ophthalmic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code HKW
FDA has cleared devices under product code HKW between 1985 and 1991, filed by 2 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
- 1991
- 1985
Top applicants under product code HKW
Recent clearances under product code HKW
Data sourced from openFDA. This site is unofficial and independent of the FDA.