HPE — Aid, Vision, Optical, Battery-Powered Class I
FDA product code HPE covers "Aid, Vision, Optical, Battery-Powered", a Class I medical device regulated under 21 CFR 886.5915. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HPE
- Device Class
- Class I
- Regulation Number
- 886.5915
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K884540 | sevrain-tech | ETV, ELECTRONIC VISION AID | January 19, 1989 |