HPM · Locator, Metal, Electronic
Ophthalmic · 21 CFR 886.4400 · Class 2
Overview
| Product Code | HPM |
|---|---|
| Device Name | Locator, Metal, Electronic |
| Regulation | 21 CFR 886.4400 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003305 | PEDIATRIC INGESTASCAN | Adams Electronics, Inc. | Dec 22, 2000 | SESE |
| K953277 | SHADOW MEDAL LOCATOR | Fatswith Intl., Inc. | Apr 1, 1996 | SESE |
| K911886 | PMT METAL LOCATOR, MODEL 3630-1 | Pmt Corp. | Aug 12, 1991 | SESE |
| K781892 | LOCATOR, FOREIGN BODY | Keeler Optical Products , Ltd. | Dec 4, 1978 | SESE |
Top Applicants
- Pmt Corp. — 1 clearance
- Keeler Optical Products , Ltd. — 1 clearance
- Fatswith Intl., Inc. — 1 clearance
- Adams Electronics, Inc. — 1 clearance
