Lens, Contact, Orthokeratology, Overnight
The Overnight Orthokeratology Contact Lens is a rigid contact lens worn overnight to temporarily reduce myopia or other refractive errors through controlled corneal reshaping, allowing improved unaided vision during the day. This lens type involves overnight corneal contact, raising safety considerations that require the most stringent regulatory review. As an FDA Class 3 device regulated under 21 CFR 886.5916 in the Ophthalmic specialty, it requires Premarket Approval (PMA). The product code is NUU. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUU
- Device Class
- FDA class 3
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 2
Device Characteristics
Definition
Temporary reduction of myopia or refractive error.
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.