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FDA 510(k)

STELLARIS PC VISION ENHANCEMENT SYSTEM

K-Number: K101325 · 2010-08-17

ApplicantBausch & Lomb, Inc.
Decision Date2010-08-17
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STELLARIS PC VISION ENHANCEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K101325. 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 STELLARIS PC VISION ENHANCEMENT SYSTEM?

STELLARIS PC VISION ENHANCEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K101325.

When did STELLARIS PC VISION ENHANCEMENT SYSTEM receive FDA 510(k) clearance?

STELLARIS PC VISION ENHANCEMENT SYSTEM received FDA 510(k) clearance on 2010-08-17, under 510(k) number K101325.

Who is the listed applicant for STELLARIS PC VISION ENHANCEMENT SYSTEM?

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

What is the FDA product code for STELLARIS PC VISION ENHANCEMENT SYSTEM?

The FDA product code for STELLARIS PC VISION ENHANCEMENT SYSTEM is HQC.

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Other records listing Bausch & Lomb, Inc. as applicant

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K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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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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