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FDA 510(k)

LENSSX LASER SYSTEM

K-Number: K120732 · 2012-09-06

ApplicantAlcon Lensx, Inc.
Decision Date2012-09-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSSX LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Lensx, Inc.. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K120732. 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 LENSSX LASER SYSTEM?

LENSSX LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Alcon Lensx, Inc.. The 510(k) number is K120732.

When did LENSSX LASER SYSTEM receive FDA 510(k) clearance?

LENSSX LASER SYSTEM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K120732.

Who is the listed applicant for LENSSX LASER SYSTEM?

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

What is the FDA product code for LENSSX LASER SYSTEM?

The FDA product code for LENSSX LASER 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alcon Lensx, 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.

K123120LENSX LASER SYSTEM

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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