Clearance Summary
SOFTRANS INJECTOR received FDA 510(k) clearance under submission number K913626, sponsored by Staar Surgical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-12-18.
- Submission: K913626
- Applicant / Sponsor: Staar Surgical Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class III
- Regulation citation: 21 CFR 886.3600
- Decision date: 1991-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HQL and 21 CFR 886.3600, within the Ophthalmic review panel as a Class III device.