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FDA 510(k)

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

K-Number: K912904 · 1992-06-11

ApplicantMentor O & O, Inc.
Decision Date1992-06-11
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1992-06-11 under 510(k) number K912904. 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 MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM?

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-11. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K912904.

When did MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM receive FDA 510(k) clearance?

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM received FDA 510(k) clearance on 1992-06-11, under 510(k) number K912904.

Who is the listed applicant for MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM?

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

What is the FDA product code for MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM?

The FDA product code for MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM is HQC.

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Other records listing Mentor O & O, 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.

K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK915340MENTOR HORIZON LOW VISION MAGNIFIERK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305K903878MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

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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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