Clearance Summary
LASER PROTECTIVE EYESHIELD received FDA 510(k) clearance under submission number K833232, sponsored by Stefanovsky & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-12-30.
- Submission: K833232
- Applicant / Sponsor: Stefanovsky & Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 1983-12-30
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.