Clearance Summary
R:GEN Laser System received FDA 510(k) clearance under submission number K153769, sponsored by Lutronic Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2016-10-05.
- Submission: K153769
- Applicant / Sponsor: Lutronic Corporation
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2016-10-05
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.