Clearance Summary
PLASTIC OPTICAL LENS M-110 received FDA 510(k) clearance under submission number K834261, sponsored by U-Molde Systems, 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 1984-03-16.
- Submission: K834261
- Applicant / Sponsor: U-Molde Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1984-03-16
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.