Clearance Summary
O-020 LASER INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K890787, sponsored by Hgm Medical Laser Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1989-03-24.
- Submission: K890787
- Applicant / Sponsor: Hgm Medical Laser Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 1989-03-24
Classification & Regulation
This clearance is catalogued under FDA product code HGF and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.