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FDA 510(k)

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS

K-Number: K122829 · 2012-12-03

ApplicantLensar, Inc.
Decision Date2012-12-03
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2012-12-03 under 510(k) number K122829. 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 LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS?

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS is a medical device that received FDA 510(k) clearance on 2012-12-03. The listed applicant is Lensar, Inc.. The 510(k) number is K122829.

When did LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS receive FDA 510(k) clearance?

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS received FDA 510(k) clearance on 2012-12-03, under 510(k) number K122829.

Who is the listed applicant for LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS?

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

What is the FDA product code for LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS?

The FDA product code for LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS is HQC.

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Other records listing Lensar, 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.

K220259ALLY Adaptive Cataract Treatment SystemK182795LENSAR Laser System - fs 3D (LLS-fs 3D)K181430LENSAR Laser System - fs 3D (LLS-fs 3D)K173346LENSAR Laser System - fs 3D (LLS-fs 3D)K171337LENSAR Laser System – fs 3D (LLS-fs 3D)K170576LENSAR Laser System - fs 3D (LLS-fs 3D)

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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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