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FDA 510(k)

MICOR 700 with Auto I/A

K-Number: K243395 · 2025-08-08

ApplicantCarl Zeiss Meditec Cataract Technology, Inc.
Decision Date2025-08-08
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MICOR 700 with Auto I/A is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243395. 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 MICOR 700 with Auto I/A?

MICOR 700 with Auto I/A is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K243395.

When did MICOR 700 with Auto I/A receive FDA 510(k) clearance?

MICOR 700 with Auto I/A received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243395.

Who is the listed applicant for MICOR 700 with Auto I/A?

The FDA 510(k) record lists Carl Zeiss Meditec Cataract Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICOR 700 with Auto I/A?

The FDA product code for MICOR 700 with Auto I/A is HQC.

Other records listing Carl Zeiss Meditec Cataract Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)K214028MICOR Lens Fragmentation SystemK222236miCOR System Lens Fragmentation SystemK200207xPORT S Lens Fragmentation SystemK200584xPORT 304 (miCOR) System Lens Fragmentation SystemK191024xPORT Lens Fragmentation System

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Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, IncorporatedK233398Faros Surgical SystemOertli Instrumente AG

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.

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