Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WaveLight FS200 Patient Interface

K-Number: K190392 · 2019-03-26

ApplicantAlcon Laboratories, Inc.
Decision Date2019-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WaveLight FS200 Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190392. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WaveLight FS200 Patient Interface?

WaveLight FS200 Patient Interface is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K190392.

When did WaveLight FS200 Patient Interface receive FDA 510(k) clearance?

WaveLight FS200 Patient Interface received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190392.

Who is the listed applicant for WaveLight FS200 Patient Interface?

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

What is the FDA product code for WaveLight FS200 Patient Interface?

The FDA product code for WaveLight FS200 Patient Interface is GEX. This falls under the Gastroenterology category.

Other records listing Alcon Laboratories, 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.

PMA P840064AID, SURGICAL, VISCOELASTICPMA P930014intraocular lensPMA P190018intraocular lensPMA P010019Lenses, soft contact, extended wearPMA P220007Lenses, soft contact, extended wearK254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

View all 50 devices →

Related Devices (Code: GEX)

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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.

↑