Clearance Summary
WOODLYN FULL APERTURE TRIAL LENS SET received FDA 510(k) clearance under submission number K900478, sponsored by Woodlyn, 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 1990-02-21.
- Submission: K900478
- Applicant / Sponsor: Woodlyn, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1405
- Decision date: 1990-02-21
Classification & Regulation
This clearance is catalogued under FDA product code HPC and 21 CFR 886.1405, within the Ophthalmic review panel as a Class I device.