Clearance Summary
SPECTACLE FRAME received FDA 510(k) clearance under submission number K851130, sponsored by New Brillette A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-05-30.
- Submission: K851130
- Applicant / Sponsor: New Brillette A/S
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1985-05-30
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.