Clearance Summary
SOFT LENS INSERTER received FDA 510(k) clearance under submission number K780931, sponsored by Soft-Sert. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1978-06-28.
- Submission: K780931
- Applicant / Sponsor: Soft-Sert
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5420
- Decision date: 1978-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KYE and 21 CFR 886.5420, within the Ophthalmic review panel as a Class I device.