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FDA 510(k)

FEMTEC LASER SYSTEM FOR CAPSULOTOMY

K-Number: K110427 · 2011-11-22

ApplicantTechnolas Perfect Vision GmbH
Decision Date2011-11-22
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FEMTEC LASER SYSTEM FOR CAPSULOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Technolas Perfect Vision GmbH. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K110427. 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 FEMTEC LASER SYSTEM FOR CAPSULOTOMY?

FEMTEC LASER SYSTEM FOR CAPSULOTOMY is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Technolas Perfect Vision GmbH. The 510(k) number is K110427.

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

FEMTEC LASER SYSTEM FOR CAPSULOTOMY received FDA 510(k) clearance on 2011-11-22, under 510(k) number K110427.

Who is the listed applicant for FEMTEC LASER SYSTEM FOR CAPSULOTOMY?

The FDA 510(k) record lists Technolas Perfect Vision GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTEC LASER SYSTEM FOR CAPSULOTOMY?

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

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Other records listing Technolas Perfect Vision GmbH 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.

K200724VICTUS Femtosecond Laser PlatformK171014VICTUS Femtosecond Laser PlatformK122386VICTUS FEMTOSECOND LASER PLATFORMK120426VICTUS LASER PLATFORMK984443ORBSCAN

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

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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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