Clearance Summary
SPECTACLE FRAMES received FDA 510(k) clearance under submission number K941211, sponsored by H & M Optical (U.S.A.) , 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: K941211
- Applicant / Sponsor: H & M Optical (U.S.A.) , 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.