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FDA 510(k)

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

K-Number: K002812 · 2000-11-08

ApplicantMichael Reynard, M.D.
Decision Date2000-11-08
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Michael Reynard, M.D.. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K002812. 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 IRIS RETRACTING PHACOEMULSIFICATION SLEEVE?

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is Michael Reynard, M.D.. The 510(k) number is K002812.

When did IRIS RETRACTING PHACOEMULSIFICATION SLEEVE receive FDA 510(k) clearance?

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE received FDA 510(k) clearance on 2000-11-08, under 510(k) number K002812.

Who is the listed applicant for IRIS RETRACTING PHACOEMULSIFICATION SLEEVE?

The FDA 510(k) record lists Michael Reynard, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIS RETRACTING PHACOEMULSIFICATION SLEEVE?

The FDA product code for IRIS RETRACTING PHACOEMULSIFICATION SLEEVE is HQC.

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Other records listing Michael Reynard, M.D. 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.

K964018PHACOILLUMINATOR - FIBEROPTIC SLEEVE

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 AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 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, Incorporated

Official Source

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

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