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FDA 510(k)

PHAKOSYSTEMS MODEL CES 4100

K-Number: K851674 · 1985-08-05

ApplicantPhakosystems, Inc.
Decision Date1985-08-05
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHAKOSYSTEMS MODEL CES 4100 is the device name listed in this FDA 510(k) record. The listed applicant is Phakosystems, Inc.. It received FDA 510(k) clearance on 1985-08-05 under 510(k) number K851674. 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 PHAKOSYSTEMS MODEL CES 4100?

PHAKOSYSTEMS MODEL CES 4100 is a medical device that received FDA 510(k) clearance on 1985-08-05. The listed applicant is Phakosystems, Inc.. The 510(k) number is K851674.

When did PHAKOSYSTEMS MODEL CES 4100 receive FDA 510(k) clearance?

PHAKOSYSTEMS MODEL CES 4100 received FDA 510(k) clearance on 1985-08-05, under 510(k) number K851674.

Who is the listed applicant for PHAKOSYSTEMS MODEL CES 4100?

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

What is the FDA product code for PHAKOSYSTEMS MODEL CES 4100?

The FDA product code for PHAKOSYSTEMS MODEL CES 4100 is HQC.

Related Clinical Trials

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.

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Other records listing Phakosystems, 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.

K880081VISION CARE/PHAKOSYSTEMS ECHOPACHK871938VISION CARE/PHAKOSYSTEMS ECHORULEK860236PHAKOSYSTEMS CT-100 CAUTERY MODULEK830871PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

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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