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WaveLight FS200 Patient Interface

Alcon Laboratories, Inc.

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Alcon Laboratories, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K190392
Device name
WaveLight FS200 Patient Interface
Company
Alcon Laboratories, Inc.
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-02-19
Decision date
2019-03-26
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The WaveLight® FS200 Patient Interface 1515 is indicated to be used only with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Intended Use

The WaveLight® FS200 Patient Interface 1515 is indicated to be used only with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

Device Description

The WaveLight® FS200 Patient Interface 1515 is a patient contact consumable (disposable) consisting of a tubing system with an integrated suction ring and an applanation cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

Summary parsed at:2026-06-01 05:55:11 UTC

Predicate devices

2

K190392 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K190392 as a predicate