Magnet, Permanent
An Ophthalmic Permanent Magnet is a non-powered surgical instrument that uses permanent magnetic force to attract and extract ferromagnetic foreign bodies from the eye or periorbital tissues without requiring an external power source. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HPN and is regulated under 21 CFR 886.4445, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.
Basic Information
- Product Code
- HPN
- Device Class
- FDA class 1
- Regulation Number
- 886.4445
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K905237 | EYE SEE INSTRUMENT | Feb 14, 1991 | Substantially Equivalent | KING TOOL, INC. |
| K896473 | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR | Feb 09, 1990 | Substantially Equivalent | EMORY UNIVERSITY SCHOOL OF MEDICINE |
| K880855 | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | Apr 01, 1988 | Substantially Equivalent | RICHARD JAMES, INC. |
| K860960 | RARE EARTH INTRA-OCULAR MAGNET | Mar 31, 1986 | Substantially Equivalent | AMERITEK, INC. |
| K831702 | RARE-EARTH INTRA-OCULAR MAGNET | Jun 30, 1983 | Substantially Equivalent | MIAMI EYE TECHNOLOGY, INC. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.