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FDA 510(k)

DIGNITY OPHTHALMIC SURGICAL SYSTEM

K-Number: K031404 · 2003-05-22

ApplicantPhacor Inc., A Santen Company
Decision Date2003-05-22
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGNITY OPHTHALMIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phacor Inc., A Santen Company. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031404. 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 DIGNITY OPHTHALMIC SURGICAL SYSTEM?

DIGNITY OPHTHALMIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Phacor Inc., A Santen Company. The 510(k) number is K031404.

When did DIGNITY OPHTHALMIC SURGICAL SYSTEM receive FDA 510(k) clearance?

DIGNITY OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031404.

Who is the listed applicant for DIGNITY OPHTHALMIC SURGICAL SYSTEM?

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

What is the FDA product code for DIGNITY OPHTHALMIC SURGICAL SYSTEM?

The FDA product code for DIGNITY OPHTHALMIC SURGICAL SYSTEM is HQC.

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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

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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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