Clearance Summary
OPTO HYALUS GREEN LASER received FDA 510(k) clearance under submission number K111460, sponsored by Opto Eletronica S/A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2012-08-20.
- Submission: K111460
- Applicant / Sponsor: Opto Eletronica S/A
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2012-08-20
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.