Product Code: HPM
FDA class 2
21 CFR 886.4400
Locator, Metal, Electronic
Ophthalmic
An Electronic Metal Locator is a diagnostic ophthalmic device that uses electronic detection technology to locate metallic foreign bodies within or around the eye, assisting the surgeon in planning and executing the removal of intraocular or intraorbital metallic fragments. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPM and is regulated under 21 CFR 886.4400, within the Ophthalmic medical specialty.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
22
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Basic Information
- Product Code
- HPM
- Device Class
- FDA class 2
- Regulation Number
- 886.4400
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003305 | PEDIATRIC INGESTASCAN | Dec 22, 2000 | Substantially Equivalent | Adams Electronics, Inc. |
| K953277 | SHADOW MEDAL LOCATOR | Apr 01, 1996 | Substantially Equivalent | Fatswith Intl., Inc. |
| K911886 | PMT METAL LOCATOR, MODEL 3630-1 | Aug 12, 1991 | Substantially Equivalent | Pmt Corp. |
| K781892 | LOCATOR, FOREIGN BODY | Dec 04, 1978 | Substantially Equivalent | Keeler Optical Products , Ltd. |