Clearance Summary
CATALYS Precision Laser System received FDA 510(k) clearance under submission number K210701, sponsored by Amo Manufacturing USA, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-04-07.
- Submission: K210701
- Applicant / Sponsor: Amo Manufacturing USA, LLC
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2021-04-07
Classification & Regulation
This clearance is catalogued under FDA product code OOE and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.