Clearance Summary
PASCAL LASER INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K123056, sponsored by Topcon Medical Laser Systems, Inc. (Tmls). The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2012-11-13.
- Submission: K123056
- Applicant / Sponsor: Topcon Medical Laser Systems, Inc. (Tmls)
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2012-11-13
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.