HJZ · Crutch, Ptosis
Ophthalmic · 21 CFR 886.5600 · Class 1
Overview
| Product Code | HJZ |
|---|---|
| Device Name | Crutch, Ptosis |
| Regulation | 21 CFR 886.5600 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.
Classification Rationale
Class I (general 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (0)
No cleared devices on record.
