Clearance Summary
OMYL -ARDE- SPECTACLE FRAME received FDA 510(k) clearance under submission number K833401, sponsored by I.J. Langleb , 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 1984-02-21.
- Submission: K833401
- Applicant / Sponsor: I.J. Langleb , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1984-02-21
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.