Clearance Summary
FRAMES, SPECTACLES received FDA 510(k) clearance under submission number K932772, sponsored by Optical Designs and Sourcing, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-09-20.
- Submission: K932772
- Applicant / Sponsor: Optical Designs and Sourcing, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1993-09-20
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.