Marker, Sclera
The Sclera Marker is a surgical ophthalmic instrument used to mark precise reference points or measurements on the surface of the sclera (the white outer coat of the eye) prior to or during ophthalmic surgical procedures such as retinal surgery or strabismus correction. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HMQ, regulated under 21 CFR 886.4570, within the Ophthalmic medical specialty. No special risk flags apply to this device.
Research product code HMQ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HMQ
- Device Class
- FDA class 1
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.