HPA — Frame, Trial, Ophthalmic Class I
FDA product code HPA covers "Frame, Trial, Ophthalmic", a Class I medical device regulated under 21 CFR 886.1415. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HPA
- Device Class
- Class I
- Regulation Number
- 886.1415
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K852548 | ascon medical instruments | ATL 225 MW TRAIL LENS SET | July 31, 1985 |
| K852126 | ascon medical instruments | ATF 101 TRAIL FRAME | June 5, 1985 |
| K841768 | woodlyn | WOODLYN LIGHTWEIGHT TRIAL FRAME | June 1, 1984 |
| K833669 | michael onufryk | IMAGE DEFLECTOR | March 27, 1984 |
| K821084 | medical equipment designs | UNIVERSAL TRIAL FRAMEE | June 14, 1982 |