Clearance Summary
ROPHAE DIAMOND KNIFE received FDA 510(k) clearance under submission number K861491, sponsored by Rophae Lens Co., 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 1986-05-28.
- Submission: K861491
- Applicant / Sponsor: Rophae Lens Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1986-05-28
Classification & Regulation
This clearance is catalogued under FDA product code HNN and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.