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FDA 510(k)

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

K-Number: K102727 · 2011-03-16

ApplicantLensar, Inc.
Decision Date2011-03-16
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K102727. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY?

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Lensar, Inc.. The 510(k) number is K102727.

When did LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY receive FDA 510(k) clearance?

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY received FDA 510(k) clearance on 2011-03-16, under 510(k) number K102727.

Who is the listed applicant for LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY?

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 FOR ANTERIOR CAPSULOTOMY?

The FDA product code for LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY is OOE.

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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: OOE)

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.

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLCK220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

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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