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FDA 510(k)

UNITED SONICS PHACO MODULE, DF-35

K-Number: K851210 · 1985-05-31

ApplicantUnited Sonics, Inc.
Decision Date1985-05-31
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNITED SONICS PHACO MODULE, DF-35 is the device name listed in this FDA 510(k) record. The listed applicant is United Sonics, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K851210. 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 UNITED SONICS PHACO MODULE, DF-35?

UNITED SONICS PHACO MODULE, DF-35 is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is United Sonics, Inc.. The 510(k) number is K851210.

When did UNITED SONICS PHACO MODULE, DF-35 receive FDA 510(k) clearance?

UNITED SONICS PHACO MODULE, DF-35 received FDA 510(k) clearance on 1985-05-31, under 510(k) number K851210.

Who is the listed applicant for UNITED SONICS PHACO MODULE, DF-35?

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

What is the FDA product code for UNITED SONICS PHACO MODULE, DF-35?

The FDA product code for UNITED SONICS PHACO MODULE, DF-35 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 United Sonics, 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.

K851211PHACO PAK IK851209CILCO/UNITED SONICS PHACE PF-9000K851212UNITED SONICS PACO SYSTEM MODEL 3000K851298MID LABS MVSXI

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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