Clearance Summary
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT received FDA 510(k) clearance under submission number K964338, sponsored by Rudolf Riester GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-01-09.
- Submission: K964338
- Applicant / Sponsor: Rudolf Riester GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1780
- Decision date: 1997-01-09
Classification & Regulation
This clearance is catalogued under FDA product code HKM and 21 CFR 886.1780, within the Ophthalmic review panel as a Class I device.