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FDA 510(k)

PHAKO KIT

K-Number: K830379 · 1983-04-05

ApplicantVxtra Corp.
Decision Date1983-04-05
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHAKO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vxtra Corp.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830379. 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 PHAKO KIT?

PHAKO KIT is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Vxtra Corp.. The 510(k) number is K830379.

When did PHAKO KIT receive FDA 510(k) clearance?

PHAKO KIT received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830379.

Who is the listed applicant for PHAKO KIT?

The FDA 510(k) record lists Vxtra Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHAKO KIT?

The FDA product code for PHAKO KIT is HQC.

Related Clinical Trials

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Other records listing Vxtra Corp. 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.

K832980VXTRA OCUTOME KITK832938OCUTOME PARATUBING SETK831266MICROSURGICAL KNIFEK830385IRRIGATION/ASPIRATION KITK812620ADJUSTABLE MICROSURGICAL KNIFEK812526MICRO BLADE II

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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 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

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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