Clearance Summary
5010 VISUSTIM received FDA 510(k) clearance under submission number K822919, sponsored by Life-Tech Intl., 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 1982-12-28.
- Submission: K822919
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1630
- Decision date: 1982-12-28
Classification & Regulation
This clearance is catalogued under FDA product code HLX and 21 CFR 886.1630, within the Ophthalmic review panel as a Class II device.