Clearance Summary
SPECTABLE FRAME MAGNIFYING BRILLETTE received FDA 510(k) clearance under submission number K844657, sponsored by Pro Design Intl. AS. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-12-11.
- Submission: K844657
- Applicant / Sponsor: Pro Design Intl. AS
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1810
- Decision date: 1984-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HOJ and 21 CFR 886.1810, within the Ophthalmic review panel as a Class I device.