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FDA 510(k)

SOLOS EYESITE CAP SLEEVE

K-Number: K872611 · 1987-08-10

ApplicantSolos Ophthalmology
Decision Date1987-08-10
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLOS EYESITE CAP SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Solos Ophthalmology. It received FDA 510(k) clearance on 1987-08-10 under 510(k) number K872611. 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 SOLOS EYESITE CAP SLEEVE?

SOLOS EYESITE CAP SLEEVE is a medical device that received FDA 510(k) clearance on 1987-08-10. The listed applicant is Solos Ophthalmology. The 510(k) number is K872611.

When did SOLOS EYESITE CAP SLEEVE receive FDA 510(k) clearance?

SOLOS EYESITE CAP SLEEVE received FDA 510(k) clearance on 1987-08-10, under 510(k) number K872611.

Who is the listed applicant for SOLOS EYESITE CAP SLEEVE?

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

What is the FDA product code for SOLOS EYESITE CAP SLEEVE?

The FDA product code for SOLOS EYESITE CAP SLEEVE 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 Solos Ophthalmology 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.

K874334SOLOS SINGLE USE TITANIUM TIPK872610SOLOS EYESITE CANNULASK872612SOLOS EYESITE SPONGESK872620SOLOS EYESITE DRAPES

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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