Clearance Summary
OPTHERM EXTRA FINE TIP received FDA 510(k) clearance under submission number K840426, sponsored by Suncoast Medical Manufacturers, 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 1984-05-09.
- Submission: K840426
- Applicant / Sponsor: Suncoast Medical Manufacturers, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HQP and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.