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FDA 510(k)

ULTRAKIT

K-Number: K831172 · 1983-06-08

ApplicantStaar Surgical Co.
Decision Date1983-06-08
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ULTRAKIT is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831172. 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 ULTRAKIT?

ULTRAKIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Staar Surgical Co.. The 510(k) number is K831172.

When did ULTRAKIT receive FDA 510(k) clearance?

ULTRAKIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831172.

Who is the listed applicant for ULTRAKIT?

The FDA 510(k) record lists Staar Surgical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAKIT?

The FDA product code for ULTRAKIT is HQC.

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Other records listing Staar Surgical Co. as applicant

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Related Devices (Code: HQC)

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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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