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FDA 510(k)

PHACO TIP

K-Number: K914229 · 1991-12-27

ApplicantTri-Star Ophthalmic
Decision Date1991-12-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACO TIP is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Star Ophthalmic. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K914229. 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 PHACO TIP?

PHACO TIP is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Tri-Star Ophthalmic. The 510(k) number is K914229.

When did PHACO TIP receive FDA 510(k) clearance?

PHACO TIP received FDA 510(k) clearance on 1991-12-27, under 510(k) number K914229.

Who is the listed applicant for PHACO TIP?

The FDA 510(k) record lists Tri-Star Ophthalmic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACO TIP?

The FDA product code for PHACO TIP is HQC.

Related Clinical Trials

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.

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Other records listing Tri-Star Ophthalmic 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.

K953359TRI-STAR UNIVERSAL I/A PHACO PAK

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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