Magnet, Ac-Powered
An AC-Powered Ophthalmic Magnet is an electrically powered surgical device that generates a strong electromagnetic field used to attract and remove ferromagnetic foreign bodies from within the eye or orbit, providing greater extraction force than permanent magnets for larger or more deeply embedded metallic fragments. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPO and is regulated under 21 CFR 886.4440, within the Ophthalmic medical specialty.
Basic Information
- Product Code
- HPO
- Device Class
- FDA class 2
- Regulation Number
- 886.4440
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854870 | INTRAOCULAR ELECTROMAGNET | Feb 19, 1986 | Substantially Equivalent | Mira, Inc. |
| K832950 | SCIENTRONICS 10K EYE MAGNET | Oct 19, 1983 | Substantially Equivalent | Scientific Manufacturer |
| K830336 | DORC INTRAOCULAR ELECTROMAGNET | Mar 09, 1983 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.