Clearance Summary
OPHTEC ENCLAVATION NEEDLE received FDA 510(k) clearance under submission number K030471, sponsored by Ophtec, USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-04-17.
- Submission: K030471
- Applicant / Sponsor: Ophtec, USA
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 2003-04-17
Classification & Regulation
This clearance is catalogued under FDA product code HNQ and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.