Clearance Summary
ORC ORACLE received FDA 510(k) clearance under submission number K853668, sponsored by Optical Radiation Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-10-15.
- Submission: K853668
- Applicant / Sponsor: Optical Radiation Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1985-10-15
Classification & Regulation
This clearance is catalogued under FDA product code HLQ and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.