Clearance Summary
EASY CONTROL MICRO INSERTER, MODEL ON385 received FDA 510(k) clearance under submission number K011498, sponsored by Ophtec USA, 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 2001-07-09.
- Submission: K011498
- Applicant / Sponsor: Ophtec USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2001-07-09
Classification & Regulation
This clearance is catalogued under FDA product code NCE and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.