Clearance Summary
MULTIPLE LENS, SPECTACLES, CUSTOM received FDA 510(k) clearance under submission number K842187, sponsored by Pavuna , 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 1984-12-11.
- Submission: K842187
- Applicant / Sponsor: Pavuna , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1984-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.