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FDA 510(k)

OCUSYSTEM IIE

K-Number: K926381 · 1993-12-06

ApplicantSurgeon Design
Decision Date1993-12-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCUSYSTEM IIE is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Design. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K926381. 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 OCUSYSTEM IIE?

OCUSYSTEM IIE is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Surgeon Design. The 510(k) number is K926381.

When did OCUSYSTEM IIE receive FDA 510(k) clearance?

OCUSYSTEM IIE received FDA 510(k) clearance on 1993-12-06, under 510(k) number K926381.

Who is the listed applicant for OCUSYSTEM IIE?

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

What is the FDA product code for OCUSYSTEM IIE?

The FDA product code for OCUSYSTEM IIE is HQC.

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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

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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