Clearance Summary
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND received FDA 510(k) clearance under submission number K132042, sponsored by X6d, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2014-04-28.
- Submission: K132042
- Applicant / Sponsor: X6d, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 2014-04-28
Classification & Regulation
This clearance is catalogued under FDA product code HOY and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.