Clearance Summary
CLAS PHOTOKERATOSCOPE received FDA 510(k) clearance under submission number K895741, sponsored by Kera-Metrics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-07-11.
- Submission: K895741
- Applicant / Sponsor: Kera-Metrics Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1990-07-11
Classification & Regulation
This clearance is catalogued under FDA product code HLQ and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.