Clearance Summary
CARRIAZO-PENDULAR MICROKERATOME received FDA 510(k) clearance under submission number K082043, sponsored by Schwind Eye-Tech-Solutions GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-08-01.
- Submission: K082043
- Applicant / Sponsor: Schwind Eye-Tech-Solutions GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2008-08-01
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.