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FDA 510(k)

PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM

K-Number: K862021 · 1986-06-23

ApplicantUltramed, Inc.
Decision Date1986-06-23
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultramed, Inc.. It received FDA 510(k) clearance on 1986-06-23 under 510(k) number K862021. 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 PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM?

PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-23. The listed applicant is Ultramed, Inc.. The 510(k) number is K862021.

When did PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM receive FDA 510(k) clearance?

PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM received FDA 510(k) clearance on 1986-06-23, under 510(k) number K862021.

Who is the listed applicant for PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM?

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

What is the FDA product code for PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM?

The FDA product code for PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM 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 Ultramed, 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.

K882015TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEMK873989DOPPLEX ULTRASONIC DOPPLER SYSTEMK861378ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYSTK850578PHACOEMULSIFICATION TIP

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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