Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

xPORT S Lens Fragmentation System

K-Number: K200207 · 2020-10-15

ApplicantCarl Zeiss Meditec Cataract Technology, Inc.
Decision Date2020-10-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

xPORT S Lens Fragmentation System is a medical device manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2020-10-15 under approval number K200207. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xPORT S Lens Fragmentation System?

xPORT S Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K200207.

When was xPORT S Lens Fragmentation System approved by the FDA?

xPORT S Lens Fragmentation System received FDA 510(k) clearance on 2020-10-15, under approval number K200207.

What company makes xPORT S Lens Fragmentation System?

xPORT S Lens Fragmentation System is manufactured by Carl Zeiss Meditec Cataract Technology, Inc..

What is the FDA product code for xPORT S Lens Fragmentation System?

The FDA product code for xPORT S Lens Fragmentation System is HQC.

Related Clinical Trials

NCT07512973 Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic Myomectomy NOT_YET_RECRUITING

Other Devices by Carl Zeiss Meditec Cataract Technology, Inc.

K191024xPORT Lens Fragmentation System K200584xPORT 304 (miCOR) System Lens Fragmentation System K214028MICOR Lens Fragmentation System K222236miCOR System Lens Fragmentation System K243395MICOR 700 with Auto I/A K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

View all 7 devices →

Related Devices (Code: HQC)

K160236Dual Pump PackAbbott Medical Optics, Inc. K170052Stellaris Elite vision enhancement systemBausch+Lomb K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb K191650LEGION SystemAlcon Research, LLC K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑