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FDA 510(k)

PHACOEMULSIFIER MODEL 100

K-Number: K890080 · 1989-04-06

ApplicantSonic Needle Corp.
Decision Date1989-04-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACOEMULSIFIER MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Needle Corp.. It received FDA 510(k) clearance on 1989-04-06 under 510(k) number K890080. 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 PHACOEMULSIFIER MODEL 100?

PHACOEMULSIFIER MODEL 100 is a medical device that received FDA 510(k) clearance on 1989-04-06. The listed applicant is Sonic Needle Corp.. The 510(k) number is K890080.

When did PHACOEMULSIFIER MODEL 100 receive FDA 510(k) clearance?

PHACOEMULSIFIER MODEL 100 received FDA 510(k) clearance on 1989-04-06, under 510(k) number K890080.

Who is the listed applicant for PHACOEMULSIFIER MODEL 100?

The FDA 510(k) record lists Sonic Needle Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACOEMULSIFIER MODEL 100?

The FDA product code for PHACOEMULSIFIER MODEL 100 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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