Clearance Summary
SCLERAL POWDER received FDA 510(k) clearance under submission number K791923, sponsored by Ocularists , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-01-10.
- Submission: K791923
- Applicant / Sponsor: Ocularists , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.3200
- Decision date: 1980-01-10
Classification & Regulation
This clearance is catalogued under FDA product code HQH and 21 CFR 886.3200, within the Ophthalmic review panel as a Class I device.