Clearance Summary
SPECTACLE FRAMES, READING GLASSES received FDA 510(k) clearance under submission number K941463, sponsored by Well Arts Optical Factory , 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 1994-06-17.
- Submission: K941463
- Applicant / Sponsor: Well Arts Optical Factory , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1994-06-17
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.