21 CFR 886.4400 — Locator, Metal, Electronic
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4400
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPM | Locator, Metal, Electronic | 2 | 4 |
Special Controls
HPM — Locator, Metal, Electronic
*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.
eCFR
