Product code HPE— Ophthalmic
ETV, ELECTRONIC VISION AID
- Classification name
- Aid, Vision, Optical, Battery-Powered
- Device class
- Class 1
- Regulation
- 21 CFR 886.5915
- Advisory panel
- Ophthalmic
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code HPE
FDA has cleared device under product code HPE, all in 1989, filed by 1 applicant company. 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.
Top applicants under product code HPE
Recent clearances under product code HPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.