HPG — Aid, Vision, Electronic, Battery-Powered Class I
FDA product code HPG covers "Aid, Vision, Electronic, Battery-Powered", a Class I medical device regulated under 21 CFR 886.5900. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HPG
- Device Class
- Class I
- Regulation Number
- 886.5900
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K910601 | nurion industries | PATHFINDER | May 14, 1991 |
| K910124 | triangle investments | LOW VISION ENHANCEMENT SYSTEM (LVES) | April 10, 1991 |
| K903558 | nurion industries | LASER CANE | September 27, 1990 |
| K902187 | nurion industries | POLARON | August 8, 1990 |
| K862338 | brytech | SENSORY 6 | September 3, 1986 |
| K823385 | oms | ALES | March 9, 1983 |
| K761215 | itt | F4912 NIGHT VISION AID | December 16, 1976 |