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FDA 510(k)

PRO-PHACO HANDPIECE

K-Number: K933503 · 1994-01-06

ApplicantM. Imonti and Associates Inc.,
Decision Date1994-01-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRO-PHACO HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K933503. 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 PRO-PHACO HANDPIECE?

PRO-PHACO HANDPIECE is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K933503.

When did PRO-PHACO HANDPIECE receive FDA 510(k) clearance?

PRO-PHACO HANDPIECE received FDA 510(k) clearance on 1994-01-06, under 510(k) number K933503.

Who is the listed applicant for PRO-PHACO HANDPIECE?

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

What is the FDA product code for PRO-PHACO HANDPIECE?

The FDA product code for PRO-PHACO HANDPIECE is HQC.

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Other records listing M. Imonti and Associates 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.

K950800PRO-PAK FOR OMS DIPLOMATEK950799PRO-VITK933627PHACOFRAGMENTOR TIPK924551ENDO TRACHEA TUBE FIXATIONK905766DRAINAGE TUBE RESTRAINT/WOUND COVER

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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