Clearance Summary
SILHOUETTE, SUNLIMETED,ADIDAS received FDA 510(k) clearance under submission number K944160, sponsored by Silhouette Optical , 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 1994-09-28.
- Submission: K944160
- Applicant / Sponsor: Silhouette Optical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1994-09-28
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.