Clearance Summary
ADAPT, MODEL AX-03SN received FDA 510(k) clearance under submission number K100954, sponsored by Apeliotus Vision Science, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-02-25.
- Submission: K100954
- Applicant / Sponsor: Apeliotus Vision Science, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1050
- Decision date: 2011-02-25
Classification & Regulation
This clearance is catalogued under FDA product code OUM and 21 CFR 886.1050, within the Ophthalmic review panel as a Class I device.