Clearance Summary
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES received FDA 510(k) clearance under submission number K131787, sponsored by Keeler, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-12-23.
- Submission: K131787
- Applicant / Sponsor: Keeler, Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4170
- Decision date: 2013-12-23
Classification & Regulation
This clearance is catalogued under FDA product code HRN and 21 CFR 886.4170, within the Ophthalmic review panel as a Class II device.