Manufacturer
Alcon Laboratories, Inc.WaveLight FS200 Patient Interface
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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