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FDA 510(k)

MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM

K-Number: K955245 · 1996-02-12

ApplicantMentor O & O, Inc.
Decision Date1996-02-12
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR MERIDIAN 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 1996-02-12 under 510(k) number K955245. 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 MERIDIAN PHACOEMULSIFICATION SYSTEM?

MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-12. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K955245.

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

MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM received FDA 510(k) clearance on 1996-02-12, under 510(k) number K955245.

Who is the listed applicant for MENTOR MERIDIAN 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 MERIDIAN PHACOEMULSIFICATION SYSTEM?

The FDA product code for MENTOR MERIDIAN 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.

K934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR 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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