Clearance Summary
AMBLYOPIA TRAINER received FDA 510(k) clearance under submission number K800112, sponsored by Life-Tech Instruments, 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 1980-03-10.
- Submission: K800112
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1290
- Decision date: 1980-03-10
Classification & Regulation
This clearance is catalogued under FDA product code HPL and 21 CFR 886.1290, within the Ophthalmic review panel as a Class I device.