Clearance Summary
CONTACT LENS LOUPE, INSPETION LOUPE received FDA 510(k) clearance under submission number K852054, sponsored by Ascon Medical Instruments, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-09-05.
- Submission: K852054
- Applicant / Sponsor: Ascon Medical Instruments, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1420
- Decision date: 1985-09-05
Classification & Regulation
This clearance is catalogued under FDA product code HLN and 21 CFR 886.1420, within the Ophthalmic review panel as a Class I device.