Clearance Summary
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 received FDA 510(k) clearance under submission number K000544, sponsored by Labtician Ophthalmics, 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 2000-03-09.
- Submission: K000544
- Applicant / Sponsor: Labtician Ophthalmics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5810
- Decision date: 2000-03-09
Classification & Regulation
This clearance is catalogued under FDA product code HJX and 21 CFR 886.5810, within the Ophthalmic review panel as a Class I device.