FDA 510(k)

SITE ULTRASONIC EMULSIFICATION MODULE OP

K-Number: K844666 · 1984-12-27

Decision Date1984-12-27

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE ULTRASONIC EMULSIFICATION MODULE OP is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Vision Corp.. It received FDA 510(k) clearance on 1984-12-27 under 510(k) number K844666. 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 SITE ULTRASONIC EMULSIFICATION MODULE OP?

SITE ULTRASONIC EMULSIFICATION MODULE OP is a medical device that received FDA 510(k) clearance on 1984-12-27. The listed applicant is Chiron Vision Corp.. The 510(k) number is K844666.

When did SITE ULTRASONIC EMULSIFICATION MODULE OP receive FDA 510(k) clearance?

SITE ULTRASONIC EMULSIFICATION MODULE OP received FDA 510(k) clearance on 1984-12-27, under 510(k) number K844666.

Who is the listed applicant for SITE ULTRASONIC EMULSIFICATION MODULE OP?

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

What is the FDA product code for SITE ULTRASONIC EMULSIFICATION MODULE OP?

The FDA product code for SITE ULTRASONIC EMULSIFICATION MODULE OP is HQC.

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Other records listing Chiron Vision Corp. as applicant

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Related Devices (Code: HQC)

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 Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 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.