Clearance Summary
SPECTACLE FRAMES received FDA 510(k) clearance under submission number K943423, sponsored by Galilee Optics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-09-06.
- Submission: K943423
- Applicant / Sponsor: Galilee Optics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1994-09-06
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.